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Read SA, Vincent SJ, Colorado LH, Wood JM, Collins MJ. The impact of toric contact lens correction upon functional near visual performance with digital devices. Cont Lens Anterior Eye 2025:102415. [PMID: 40210522 DOI: 10.1016/j.clae.2025.102415] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2024] [Revised: 01/23/2025] [Accepted: 03/31/2025] [Indexed: 04/12/2025]
Abstract
PURPOSE Although it is well known that astigmatism correction with toric contact lenses improves clinical vision measures, their effects on real-world visual performance using digital devices such as smartphones are less well understood. This study aimed to examine how toric soft contact lenses impact functional near visual performance with a smartphone, in comparison to spherical equivalent contact lenses. METHODS Fifteen healthy young adults (mean age 23.6 ± 2.8 years) with low to moderate astigmatism (-0.50 D to -1.50 D) participated in this prospective, repeated measures randomised crossover trial. Either toric or best sphere soft daily disposable contact lenses (lens material Verofilcon A) were worn during two separate study visits. At each visit, near visual acuity (VA) was assessed, and participants performed a reading task on a smartphone with both high and low contrast text displays. A mobile eye tracker was worn during the reading task to track objective measures of visual fatigue such as palpebral aperture height and near focusing demand. RESULTS Both high and low contrast near VA were significantly better with the toric correction compared to the best sphere (p = 0.001). While reading on a smartphone, the average reading speed was not significantly different between the sphere and toric lenses (p = 0.18). Significantly fewer errors were made while reading with the toric lens compared to the best sphere lens for the low contrast (p = 0.04), but not for high contrast text (p = 0.4). For measures of palpebral aperture height, and focusing demand, a significant lens by time interaction was found (both p < 0.05), with a significantly greater focusing demand and a narrower palpebral aperture observed towards the end of the reading task with the best sphere lens. CONCLUSION Significant visual and functional benefits were found for digital near visual tasks associated with toric contact lens correction.
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Affiliation(s)
- Scott A Read
- Centre for Vision and Eye Research, Optometry & Vision Science, Queensland University of Technology, Kelvin Grove, Brisbane, Australia.
| | - Stephen J Vincent
- Centre for Vision and Eye Research, Optometry & Vision Science, Queensland University of Technology, Kelvin Grove, Brisbane, Australia
| | - Luisa H Colorado
- Centre for Vision and Eye Research, Optometry & Vision Science, Queensland University of Technology, Kelvin Grove, Brisbane, Australia
| | - Joanne M Wood
- Centre for Vision and Eye Research, Optometry & Vision Science, Queensland University of Technology, Kelvin Grove, Brisbane, Australia
| | - Michael J Collins
- Centre for Vision and Eye Research, Optometry & Vision Science, Queensland University of Technology, Kelvin Grove, Brisbane, Australia
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Qian W, Wu Y, Liu X, Liu Y, Li M, Zhao T, Chen N, Ke B. Efficacy of 0.05% cyclosporine A on tear inflammatory cytokines and goblet cell function after corneal refractive surgery. J Ophthalmic Inflamm Infect 2025; 15:36. [PMID: 40178682 PMCID: PMC11968637 DOI: 10.1186/s12348-025-00462-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2024] [Accepted: 01/27/2025] [Indexed: 04/05/2025] Open
Abstract
BACKGROUND Corneal refractive surgeries offer rapid vision correction, while dry eye disease remains a common postoperative complication that significantly impacts patients' quality of life. The etiology of postoperative dry eye is multifactorial. Cyclosporine A (CsA) has been employed in the treatment of dry eye due to its ability to suppress T cell-mediated immune responses and reduce inflammation. The present study was designed to assess the early effect of 0.05% cyclosporine A (CsA) eye drops on tear film stability, ocular surface inflammation and goblet cell function in patients following corneal refractive surgery. METHODS One hundred forty-four eyes of 72 participants undergoing corneal refractive surgery were enrolled and randomized into additional 0.05% CsA eye drops treated group or conventional schedule treated group. Ocular Surface Disease Index (OSDI), relevant ocular surface clinical parameters, tear inflammatory cytokine levels, conjunctival impression cytology, and gene expression of Keratin 7 (KRT-7) as well as Mucin5AC (Muc5AC) in conjunctival epithelial cells were measured before surgery (baseline) and at 1 month after surgery. All indicators and their changing value were compared against baseline or across different groups. RESULTS 0.05% CsA treatment exhibited greater changes in OSDI, NIBUT, LLT and CFS in the early postoperative period (P = 0.004, P = 0.002, P = 0.032, P = 0.008). Compared to control group, there was a more significant decrease in IFN-γ and TNF-α levels in tear fluid in CsA group after surgery (P = 0.012, p = 0.032). Additionally, KRT-7 and IFN-γ showed recovery in conjunctival cells with 0.05% CsA treatment (P = 0.003, P = 0.019). The postoperative KRT-7 and Muc5AC levels were negatively correlated with corresponding IFN-γ levels in tear fluid among all subjects (r = -0.200, p = 0.016; r = -0.229, p = 0.006). CONCLUSIONS For patients undergoing refractive surgery, the application of 0.05% CsA suppressed the expression of inflammatory cytokines such as IFN-γ and TNF-α, and preserved goblet cell function. These effects ultimately contribute to maintaining ocular surface stability and alleviating dry eye related symptoms during the early postoperative period following refractive surgery.
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Affiliation(s)
- Wenzhe Qian
- Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Road, Shanghai, 200080, China
- National Clinical Research Center for Eye Diseases, Shanghai, China
| | - Yue Wu
- Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Road, Shanghai, 200080, China
- National Clinical Research Center for Eye Diseases, Shanghai, China
| | - Xin Liu
- Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Road, Shanghai, 200080, China
- National Clinical Research Center for Eye Diseases, Shanghai, China
| | - Yuying Liu
- Department of Ophthalmology, Shanghai Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China
| | - Min Li
- Department of Ophthalmology, Shanghai Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China
| | - Ting Zhao
- Department of Ophthalmology, Shanghai Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China
| | - Na Chen
- Department of Ophthalmology, Shanghai Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.
| | - Bilian Ke
- Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Road, Shanghai, 200080, China.
- Department of Ophthalmology, Shanghai Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.
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Baeza DC, Sanchez V, Goldhardt R, McCoy SS, Tang F, Baer A, Fox R, Galor A. The eye as a window to oral and pain symptoms in Sjögren's disease. Br J Ophthalmol 2025:bjo-2024-326748. [PMID: 40180442 DOI: 10.1136/bjo-2024-326748] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2024] [Accepted: 02/10/2025] [Indexed: 04/05/2025]
Abstract
BACKGROUND To investigate whether certain dry eye (DE) metrics relate to oral and pain manifestations of Sjögren's disease (SjD). METHODS Secondary analysis of the Sjögren's International Collaborative Clinical Alliance dataset containing 1541 individuals with 2016 American College of Rheumatology/European League Against Rheumatism defined SjD. Binary logistic regression analyses examined which of 13 DE features related to various extraocular metrics. RESULTS The mean age of the population was 52±13.5 years; 45% identified as white and 94% as women. Heterogeneity in DE symptoms and signs was noted in individuals with SjD, with approximately one-third of individuals reporting significant spontaneous and/or evoked pain using various descriptors and indicating certain triggers, and approximately half having low tear production. Similarly, heterogeneity was noted with respect to oral and pain complaints, with extraocular pain symptoms found in approximately one-third of the population. Different ocular phenotypes aligned with different extraocular findings. Specifically, grittiness or scratchiness in the eyes (OR=1.6), blurred vision (OR=1.4) and low tear production (OR=1.8) most closely aligned with oral dryness ('Does your mouth feel dry?). On the other hand, burning or stinging in the eyes (OR=1.6), discomfort in low humidity (OR=1.2) and the absence of DE signs (normal tear production, OR=0.7; lack of ocular surface staining, OR=0.6) most closely aligned with pain outside the eye ('Do you experience persistent or frequent burning discomfort?'). CONCLUSIONS Our findings suggest heterogeneity in SjD ocular presentations that predict extraocular features of disease and hint at mechanisms that underlie heterogeneity, namely divergent neurosensory processes.
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Affiliation(s)
- Drew C Baeza
- Cornea, University of Miami Health System Bascom Palmer Eye Institute, Miami, Florida, USA
- Medicine, Nova Southeastern University Dr Kiran C Patel College of Allopathic Medicine, Fort Lauderdale, Florida, USA
| | - Victor Sanchez
- University of Miami Health System Bascom Palmer Eye Institute, Miami, Florida, USA
- University of Miami Miller School of Medicine, Miami, Florida, USA
| | - Raquel Goldhardt
- University of Miami Health System Bascom Palmer Eye Institute, Miami, Florida, USA
- Ophthalmology, Bruce W Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA
| | - Sara S McCoy
- University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA
| | - Fei Tang
- Ophthalmology, Bruce W Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA
| | - Alan Baer
- Johns Hopkins School of Medicine, Baltimore, Maryland, USA
| | - Robert Fox
- Kaizen Brain Institute, Scripps Clinic La Jolla Ximed Building, La Jolla, California, USA
| | - Anat Galor
- University of Miami Health System Bascom Palmer Eye Institute, Miami, Florida, USA
- Ophthalmology, Bruce W Carter Department of Veterans Affairs Medical Center, Miami, Florida, USA
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Chen A, Augello P, Asbell P, Ying GS. The repeatability of tests for dry eye signs and symptoms in the dry eye assessment and management (DREAM) study. Cont Lens Anterior Eye 2025; 48:102322. [PMID: 39477774 PMCID: PMC11911092 DOI: 10.1016/j.clae.2024.102322] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2024] [Revised: 10/08/2024] [Accepted: 10/19/2024] [Indexed: 03/18/2025]
Abstract
PURPOSE To assess the repeatability of measures for dry eye disease (DED) symptoms and signs in the DREAM study. METHODS At screening and baseline visits approximately 2 weeks apart, participants were assessed for symptoms by Ocular Surface Disease Index (OSDI) and Brief Ocular Discomfort Index (BODI), and signs by the same physician in the same order: tear break-up time (TBUT), corneal staining, conjunctival staining, Meibomian gland evaluation, and the Schirmer test. The repeatability of DED symptoms and signs was assessed by interclass correlation coefficient (ICC), 95 % limits of agreement, and the percent of eyes with inter-visit difference above the clinically significant threshold. RESULTS Among 1046 eyes (523 participants), ICC for signs ranged from 0.53 (TBUT) to 0.73 (corneal staining). A substantial percentage of eyes showed clinically significant inter-visit differences: ≥2 points in 17.8 % of eyes for conjunctival staining; ≥3 points in 18.8 % for corneal staining; >2 s in 14.1 % for TBUT; ≥5 mm/5 min in 29.9 % for the Schirmer test, and ≥ 2 points in 27.5 % for Meibomian gland plugging and lid secretion. The OSDI and BODI had ICC of 0.64 and 0.63 respectively, and nearly 40 % of participants had inter-visit score differences ≥ 10 points. CONCLUSION In DREAM participants with moderate-to-severe DED, DED signs and symptoms had moderate repeatability, with ocular surface staining scores being the most repeatable and TBUT the least repeatable. A notable percentage of participants had inter-visit differences above the clinically meaningful threshold. These test-retest variabilities in DED signs and symptoms should be considered for designing clinical trials and monitoring disease progression.
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Affiliation(s)
- Anna Chen
- University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States
| | - Patrick Augello
- Temple University School of Public Health, Philadelphia, PA, United States
| | - Penny Asbell
- University of Memphis, Memphis, TN, United States
| | - Gui-Shuang Ying
- Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology, University of Pennsylvania Perelman School of Medicine, United States.
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Li L, Zhu X, Xu W, Dai M, Liu Z, Li Y, Fang Y, Li J, Chen W. A prospective self-controlled study on the alterations of the ocular surface and conjunctival transcriptomic profile associated with prolonged exposure to video display terminals. Ocul Surf 2025; 36:94-105. [PMID: 39828134 DOI: 10.1016/j.jtos.2025.01.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2024] [Revised: 01/13/2025] [Accepted: 01/16/2025] [Indexed: 01/22/2025]
Abstract
PURPOSE To assess the impact of prolonged and intense exposure to video display terminals (VDTs) on ocular surface homeostasis. METHODS 30 subjects limited daily VDT usage to less than 3 h for one week, then extended usage to more than 8 h/day for the next three weeks. Ocular symptoms and signs were evaluated weekly using the Ocular Surface Disease Index (OSDI) questionnaire and clinical examinations. Eyelid margins and meibomian glands were examined, and ocular surface samples were collected for transcriptomic analysis. RESULTS Average daily VDT time increased from 2.55 ± 0.46 h initially to 11.17 ± 2.45, 11.75 ± 2.63, and 10.89 ± 2.41 h over three weeks. The dry eye diagnosis rate rose from 6.67 % to 51.67 %. Total OSDI score (P = 0.008), symptoms score (P = 0.014), and visual function score (P = 0.002) significantly increased. Mean fluorescein break-up time (FBUT) decreased from 6.46s to 3.08s. Corneal fluorescein staining (CFS) score (P < 0.001) and lissamine green conjunctival staining (LCjs) score (P = 0.036) worsened. Ocular redness index (RI) increased at 1 week and 3 weeks (P = 0.007, P = 0.001). Telangiectasia scores of both upper and lower eyelid margins increased at 3 weeks (P = 0.002, P < 0.001). Meibomian gland orifice blockage worsened (P = 0.014, P = 0.002). Transcriptomic analysis revealed dynamic alterations in ocular surface gene expression, including inflammatory and hormonal responses. MUC5AC and TFF1 genes showed negative correlations with OSDI and conjunctival staining score, respectively. CONCLUSION Prolonged VDT exposure deteriorates ocular surface symptoms and signs, with significant inflammatory responses and hormonal activity indicating an imbalance in ocular surface homeostasis.
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Affiliation(s)
- Ling Li
- Ningbo Eye Hospital, Wenzhou Medical University, Ningbo, 315042, China; National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Xinhao Zhu
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Weihao Xu
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Mali Dai
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Zihao Liu
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Yanxiao Li
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China
| | - Yiting Fang
- Hangzhou Lin'an Traditional Chinese Medicine Hospital, Hangzhou, 311300, China
| | - Jinyang Li
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China; Department of Ophthalmology, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, Quzhou, 32400, Zhejiang Province, China.
| | - Wei Chen
- National Clinical Research Center for Ocular Diseases, Eye Hospital, Wenzhou Medical University, Wenzhou, 325027, China; Ningbo Eye Institute, Ningbo Eye Hospital, Wenzhou Medical University, Ningbo, 315040, China.
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Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro ® Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther 2025; 14:787-803. [PMID: 40024993 PMCID: PMC11920458 DOI: 10.1007/s40123-025-01101-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2024] [Accepted: 01/28/2025] [Indexed: 03/04/2025] Open
Abstract
INTRODUCTION Artificial tear substitutes are key elements in the first-line treatment of dry eye disease (DED). We hypothesized that GlicoPro®, a new multimolecular complex based on proteins, sulfured and unsulfured glycosaminoglycans and opiorphin, was able to significantly improve the effect of hydroxypropyl-methylcellulose (HPMC) eyedrops in treating DED. METHODS We performed an in vitro experiment and a clinical study, comparing an HPMC + GlicoPro®-based to an HPMC-based ophthalmic formulation (similar kinematic viscosity and comparable HPMC concentration). An in vitro dry eye model was established by inducing hyperosmolarity in the base medium of human corneal epithelial cells HCE-2. After treatment with ophthalmic formulations, the expression levels of inflammatory cytokines and enzymes (IL-20, IL-1β, TNF-α, IL-6, IL-8, MMP-9, and MCP-1) was measured by real-time polymerase chain reaction. Moreover, we performed a single-blind randomized 1:1 clinical trial, aimed to compare the efficacy of the two formulations instilled four times per day (QID), in treating mild-to-moderate DED. Symptoms (Ocular Surface Disease Index and Symptom Assessment iN Dry Eye), clinical signs, and ocular surface imaging data were assessed at baseline and after 1 and 3 months of treatment. RESULTS In vitro experiment: under hyperosmotic conditions, corneal epithelial cells upregulated the expression of inflammatory cytokines IL-20, IL-1β, TNF-α, IL-6, and IL-8. Treatment with HPMC + GlicoPro® significantly decreased the expression of all inflammatory markers tested, including cytokines, MMP-9, and MCP-1 (P < 0.05). CLINICAL STUDY the HPMC + GlicoPro® formulation showed a significantly higher effect in improving symptoms (overall treatment effect: P < 0.001), tear film stability, and markers of inflammation on corneal confocal microscopy (P < 0.01). CONCLUSIONS Both in vitro and clinical data provided evidence supporting the role of GlicoPro® in improving the effect of HPMC in DED treatment. CLINICAL TRIAL REGISTRATION NCT06726525.
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Affiliation(s)
- Edoardo Villani
- Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
- Eye Clinic San Giuseppe Hospital, IRCCS Multimedica, Via San Vittore 12, 20100, Milan, Italy.
| | - Giuseppe Campagna
- Department of Medical-Surgical Sciences and Translational Medicine, University of Rome "Sapienza", Rome, Italy
| | - Valentina Gentili
- Department of Environmental and Prevention Sciences, University of Ferrara, Ferrara, Italy
| | - Elisa Imelde Postorino
- Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy
| | - Paola Genovese
- Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy
| | - Paola Palino
- Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy
| | - Gloria Maini
- Department of Environmental and Prevention Sciences, University of Ferrara, Ferrara, Italy
| | - Alice Carbucicchio
- Eye Clinic San Giuseppe Hospital, IRCCS Multimedica, Via San Vittore 12, 20100, Milan, Italy
- Faculty of Medicine, University of Milan, Milan, Italy
| | - Eleonora Ferioli
- Eye Clinic San Giuseppe Hospital, IRCCS Multimedica, Via San Vittore 12, 20100, Milan, Italy
- Faculty of Medicine, University of Milan, Milan, Italy
| | - Paolo Nucci
- Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy
| | - Roberta Rizzo
- Department of Environmental and Prevention Sciences, University of Ferrara, Ferrara, Italy
- LTTA, Clinical Research Center, University of Ferrara, Ferrara, Italy
| | - Pasquale Aragona
- Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy
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Bacharach J, Kannarr SR, Verachtert A, Gupta PK, Razeen M, Cavet ME, Vittitow JL, Lang J, Chester TM, Ziemanski JF, White DE. Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study. Ophthalmol Ther 2025; 14:693-704. [PMID: 39985746 PMCID: PMC11920460 DOI: 10.1007/s40123-025-01097-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2024] [Accepted: 01/24/2025] [Indexed: 02/24/2025] Open
Abstract
INTRODUCTION Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED) and targets excessive tear evaporation. This study evaluated patient-reported outcomes early in treatment with PFHO. METHODS This prospective, multicenter, open-label, phase 4 study enrolled adults with a history of DED for ≥ 6 months. PFHO was instilled in both eyes four times daily for 14 days. Patients completed early outcome surveys during four clinic visits (day 1 [pretreatment; 5 and 60 min post-PFHO instillation] and days 3, 7, and 14). Symptom severity, symptom frequency, and treatment satisfaction were rated on visual analog scales (range 0-100). The primary endpoint was mean change from baseline in overall DED symptom severity at day 7. Secondary endpoints included change in severity of individual DED symptoms (eye dryness, blurred vision, eye irritation, light sensitivity, eye tiredness, burning/stinging, eye itching, eye pain); change in frequency (measured as percentage of time experienced) of the most bothersome symptom, awareness of dry eye symptoms, and fluctuation in quality of vision; and treatment satisfaction. RESULTS Ninety-nine patients enrolled (85.9% female; age range 35-81 years). The primary endpoint was met: mean (SD) overall symptom severity decreased significantly from 72.1 (17.0) at baseline to 27.8 (22.3) at day 7 (mean change, - 44.5; P < 0.0001). Mean (SD) percentage of time experiencing the most bothersome symptom decreased from 77.9% at baseline to 34.7% at day 14 (P < 0.0001). Significant reductions in severity and frequency also were observed for all symptoms at all postbaseline assessments (P < 0.0001). Median ratings of treatment satisfaction were 83.0 at day 3, 86.0 at day 7, and 90.0 at day 14. CONCLUSION Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom frequency and severity. Treatment satisfaction with PFHO was high. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT06309953.
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Affiliation(s)
- Jason Bacharach
- North Bay Eye Associates, Inc., 104 Lynch Creek Way, Suite 15, Petaluma, CA, 94954, USA.
| | | | | | | | | | | | | | | | | | - Jillian F Ziemanski
- Department of Optometry and Vision Science, University of Alabama at Birmingham, Birmingham, AL, USA
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Atikah A, Suzana M, Wan Haslina WAH, Norshamsiah MD, Mushawiahti M, Birinder KSS, Tang SF, Bastion MLC. Randomised controlled trial on effects of topical insulin compared to artificial tears and normal saline on tear inflammatory mediator levels and clinical parameters in diabetics with dry eye disease. Cont Lens Anterior Eye 2025; 48:102346. [PMID: 39676005 DOI: 10.1016/j.clae.2024.102346] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2023] [Revised: 11/25/2024] [Accepted: 11/28/2024] [Indexed: 12/17/2024]
Abstract
PURPOSE To assess the short-term effects of topical insulin (TI) as compared to topical Systane UltraTM (Alcon, USA) as artificial tears (AT) and topical normal saline (NS) on tear inflammatory mediators; interleukin 1-alpha (IL-1a), interleukin 6 (IL-6) and matrix metalloproteinase 9 (MMP-9) and clinical dry eye parameters in diabetics with dry eye disease (DDED). METHODS In this randomized, multi-arm parallel single-centre trial, 73 diabetics with dry eye disease (30 female and 43 male) aged 18 to 50 years were recruited. They were randomly assigned to four weeks of treatment of either TI 0.5 unit/drop, AT or NS four times per day. Tear sample analysis and clinical parameters of dry eye (Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), corneal Oxford score and Schirmers test) were evaluated at baseline and four weeks later. Objective clinical parameters for corneal Oxford score and tear break-up time were assessed by two masked investigators. RESULTS Significant reduction was seen in all inflammatory biomarkers (IL-1a, IL-6 and MMP-9) in all treatment groups at 4 weeks. In addition, inflammatory biomarkers demonstrated a significant reduction with TI (p < 0.001). Meanwhile, in AT and NS groups, reduction was also significant but less than TI group. Similarly, significant improvements were seen in all clinical parameters evaluated with all 3 treatments at 4 weeks; with TI group showing largest improvement as compared to AT and NS groups (p < 0.001). This is supported with the results as follows: mean difference -20.90 for OSDI as compared to -11.38 and -6.78 for AT and NS groups, respectively, 5.55 s for TBUT as compared to 3.00 s and 1.00 s for AT and NS group respectively, -2.40 for Oxford score as compared to -0.38 and -1.39 for AT and NS group respectively, and 5.20 mm for Schirmers test as compared to 3.00 mm and 1.00 mm for AT and NS group respectively. CONCLUSION Treatment with TI resulted in the greatest reduction in inflammatory biomarkers and ocular eye parameters, as compared to AT and NS. TI was most effective in improving clinical parameters of DDED, although all topical therapies showed significant improvements, suggesting that use of TI may be beneficial in treating DDED.
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Affiliation(s)
- A Atikah
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - M Suzana
- Department of Biochemistry, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - W A H Wan Haslina
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - M D Norshamsiah
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - M Mushawiahti
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - K S S Birinder
- Department of Pharmacy, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - S F Tang
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
| | - M L C Bastion
- Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
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Palkovits S, Schlatter A, Ruiss M, Fisus A, Bayer N, Kofler P, Findl O. Role of postoperative lubrication in preventing dry eye after cataract surgery in high- and low-risk patients stratified by ocular surface frailty index. PLoS One 2025; 20:e0312712. [PMID: 40138387 PMCID: PMC11940489 DOI: 10.1371/journal.pone.0312712] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Accepted: 01/22/2025] [Indexed: 03/29/2025] Open
Abstract
PURPOSE Symptoms and signs of dry eye can significantly increase after cataract surgery. The present study seeks to investigate the effect of intensive lubrication using Systane HYDRATION multi-dose preservative free (MDPF) eye drops (Alcon Research, Ltd., Fort Worth, Texas, USA) on signs and symptoms of dry eye in the postoperative phase. METHODS Patients scheduled for cataract surgery were enrolled in this randomised, investigator-masked study and assigned to one of three groups. The risk of developing dry eye was stratified using the ocular surface frailty index (OSFI). The high risk - standard of care (HR-SOC) and treatment (HR-Treatment) group were the high-risk groups (OSFI 0.3 or greater), and the LR-SOC group was the low-risk group (OSFI less than 0.3). HR-SOC and LR-SOC group received the standard postoperative treatment. In the HR-Treatment group, Systane HYDRATION MDPF was added four times a day for three months after surgery. After the baseline examination prior to cataract surgery, three follow up visits were scheduled one week, one month and three months after surgery. OSDI scores, ocular surface staining, and fluorescein break-up time were assessed at each visit. RESULTS Ninety-five patients were included and 83 entered statistical analyses. OSDI increased in all groups after cataract surgery, and it was lowest in the HR-Treatment group three months after the surgery. In addition, fluorescein break-up time tended to be longer and ocular surface staining less in the HR treatment group at three months. However, there was no statistically significant difference between the groups during the three-month visit. CONCLUSION In this randomized, examiner-masked trial no statistically significant difference could be found between the groups, but Systane HYDRATION MDPF may have a positive effect after cataract surgery in high-risk groups for dry eye syndrome. TRIAL REGISTRATION ClinicalTrials.gov NCT06555224.
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Affiliation(s)
- Stefan Palkovits
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Andreas Schlatter
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Manuel Ruiss
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Andreea Fisus
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Natascha Bayer
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Paul Kofler
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
| | - Oliver Findl
- VIROS—Vienna Institute for Research in Ocular Surgery, A Karl Landsteiner Institute, Hanusch Hospital, Department of Ophthalmology, Vienna, Austria
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Woi PJ, Pathmanathan P, Sieh SYH, Abd Rahman MH, Abdul Mutalib H, Bhandari M, Nordin N, Wan Din WMH. Relationship between tear film stability, dry eye symptoms, and night driving vision among Malaysian adults. PLoS One 2025; 20:e0320223. [PMID: 40138276 PMCID: PMC11940712 DOI: 10.1371/journal.pone.0320223] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2024] [Accepted: 02/16/2025] [Indexed: 03/29/2025] Open
Abstract
Background Dry eye disease, a prevalent condition globally, affects the quality of the tear film and, subsequently, vision, especially during visually demanding tasks like driving at night. This study aims to evaluate the relationship between tear film stability, dry eye symptoms, and self-reported difficulties in night driving among Malaysian adults. METHODS Ninety participants aged 18-40 years with at least one year of night driving experience were recruited. Tear film stability was assessed using non-invasive tear break-up time (NIBUT), while dry eye symptoms were measured with the Ocular Surface Disease Index (OSDI). Night driving vision difficulties were evaluated using the Vision and Night Driving Questionnaire (VND-Q). RESULTS Participants with shorter NIBUT (mean = 3.95 ± 1.32 s; median = 3.97 s, IQR: 2.87-5.03 s) reported significantly greater difficulties in night driving compared to those with normal NIBUT (mean = 9.80 ± 3.86 s; median = 8.23 s, IQR: 6.90-11.70 s) (p < 0.001). Similarly, participants with severe dry eye symptoms had higher VND-Q scores (mean rank = 76.75) compared to those with asymptomatic to moderate symptoms (mean rank = 35.68-44.03) (p < 0.001). Spearman's correlation showed moderate negative associations between NIBUT (r = -0.327), OSDI (r = -0.538), and VND-Q scores. However, there was no significant correlation between NIBUT and OSDI score. Multiple regression analysis revealed that both NIBUT and OSDI significantly predicted the VND-Q score, explaining 43.2% of the variance (p < 0.001). CONCLUSIONS The findings suggest that poor tear film stability and severe dry eye symptoms contribute to night driving difficulties. Future studies should explore interventions aimed at improving tear film stability and dry eye symptoms to enhance driving safety at night.
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Affiliation(s)
- Pui Juan Woi
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Purani Pathmanathan
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Selena Yi Han Sieh
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Mohd Harimi Abd Rahman
- Optometry and Vision Science Program, Center for Rehabilitation & Special Needs Studies (iCaRehab), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Haliza Abdul Mutalib
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Madhavendra Bhandari
- School of Optometry, Faculty of Medicine & Health Sciences, UCSI University, Cheras, Kuala Lumpur, Malaysia
| | - Naufal Nordin
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Wan Muhammad Hirzi Wan Din
- Optometry and Vision Science Program, Center for Community Health Studies (ReaCH), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
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11
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Gupta PK, Thompson V, O’Dell L, Ho AN, Chan A, Oak B, Athavale A, Yeu E. Patient-Reported Burden of Illness and Unmet Needs in Demodex blepharitis. Patient Prefer Adherence 2025; 19:647-658. [PMID: 40124965 PMCID: PMC11929423 DOI: 10.2147/ppa.s501764] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2024] [Accepted: 01/14/2025] [Indexed: 03/25/2025] Open
Abstract
Background Demodex blepharitis is an ocular disorder caused by the infestation of Demodex mites that reside on the eyelash follicles. Objective This study assessed the clinical, humanistic, and economic burden of Demodex blepharitis from a patient perspective. Methods This cross-sectional, observational study used a web-enabled survey to collect data from US adults with Demodex blepharitis in 2022. Patients with unique burdens, including those receiving dry eye disease medications, wearing contact lenses, or experiencing cataracts or glaucoma were also examined. Results Among 113 patients, mean age was 48.5 years (standard deviation [SD] ± 13.6). Half had private/commercial insurance, and 55% had Medicare and/or Medicaid. Patients had Demodex blepharitis for an average of 4.3 years (SD ± 6.7 years) before the study, and 1.2 years (SD ± 3.0 years) elapsed between the appearance of symptoms and diagnosis. Common symptoms, including redness, dryness, itchiness of the eyelids, and itchiness of the eyes, persisted or returned shortly after diagnosis and disease management in most patients, and they were associated with a negative impact on quality of life. Patients visited their healthcare practitioner for Demodex blepharitis a mean of 3.9 times (SD ± 4.8) in the preceding year. Patients were often managed with off-label prescription medications, such as medications indicated for dry eye disease, in-office procedures, or over-the-counter management options. Discussion Patients with Demodex blepharitis reported symptoms impacting their quality of life and activities of daily living, which persisted after diagnosis and disease management. This suggested that the effectiveness of the reported symptom management options was temporary and highlighted an unmet need in treating the root cause of the disease. Conclusion Patients with Demodex blepharitis were symptomatic, and the commonly used management options for Demodex blepharitis lacked long-term symptom relief or mite eradication, demonstrating a high unmet need in treating patients with Demodex blepharitis.
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Affiliation(s)
| | | | | | - Anh N Ho
- Tarsus Pharmaceuticals, Inc, Irvine, CA, USA
| | - Arthur Chan
- Tarsus Pharmaceuticals, Inc, Irvine, CA, USA
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Inomata T, Sung J, Nagino K, Midorikawa-Inomata A, Eguchi A, Adachi T, Kobayashi H, Nakao S. Profiling eyewash usage and preferences in individuals with hay fever using a digital cross-sectional cohort study with AllerSearch. Sci Rep 2025; 15:8275. [PMID: 40065121 PMCID: PMC11894135 DOI: 10.1038/s41598-025-93027-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2024] [Accepted: 03/04/2025] [Indexed: 03/14/2025] Open
Abstract
Eye washing is a common over-the-counter, self-administered method for managing hay fever-related ocular symptoms. However, epidemiological data on eyewash users with hay fever and their characteristics are limited. This study aimed to profile eyewash usage and preferences in individuals with hay fever. This digital, cross-sectional cohort study was conducted between February 2018 and May 2020. Individuals in Japan who downloaded the AllerSearch smartphone application were included. Factors associated with eyewash and non-eyewash users among patients with hay fever were assessed using multivariable logistic regression analyses. Of the 11,284 participants, 9,041 had hay fever. Among them, 40.7% were eyewash users (43.9% used eyewash products as needed during symptom flare-ups, 24.8% used them in the morning, and 19.4% in the evening). Factors associated with eyewash use included younger age, previous psychiatric illness, history of contact lens use, current contact lens use, active smoking, higher yogurt intake, lower nasal symptom score, higher non-nasal symptom score, and dry eye symptoms. Non-use of eyewash was linked to older age, sleep duration < 6 h, lower yogurt intake, and dry eye symptoms. This study elucidated characteristics and factors associated with eyewash use among individuals with hay fever, guiding an individualized approach to treatment and public health initiatives.
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Affiliation(s)
- Takenori Inomata
- Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-0033, Japan.
- Department of Hospital Administration, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan.
- Department of Telemedicine and Mobile Health, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan.
- Data Science, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan.
- ENGAGE-Task Force, Tokyo, Japan.
| | - Jaemyoung Sung
- Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-0033, Japan
| | - Ken Nagino
- Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-0033, Japan
- Department of Hospital Administration, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
- Department of Telemedicine and Mobile Health, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
| | - Akie Midorikawa-Inomata
- Department of Hospital Administration, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
- Department of Telemedicine and Mobile Health, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
| | - Atsuko Eguchi
- Department of Hospital Administration, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
| | - Takeya Adachi
- ENGAGE-Task Force, Tokyo, Japan
- Department of Dermatology, Keio University School of Medicine, Tokyo, 160-8582, Japan
- Department of Medical Innovation and Translational Medical Science, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, 602-8566, Japan
| | - Hiroyuki Kobayashi
- Department of Hospital Administration, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan
| | - Shintaro Nakao
- Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-0033, Japan
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Kwon J, Moghtader A, Kang C, Bibak Bejandi Z, Shahjahan S, Alzein A, Djalilian AR. Overview of Dry Eye Disease for Primary Care Physicians. MEDICINA (KAUNAS, LITHUANIA) 2025; 61:460. [PMID: 40142272 PMCID: PMC11943967 DOI: 10.3390/medicina61030460] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/31/2024] [Revised: 02/03/2025] [Accepted: 02/25/2025] [Indexed: 03/28/2025]
Abstract
Dry eye disease (DED), also known as keratoconjunctivitis sicca, is a multifactorial ocular disease characterized by tear film insufficiency due to diverse etiologies including aging, incomplete and infrequent blinking, hormonal changes, medications, and systemic diseases. Classified into aqueous-deficient dry eye (ADDE), evaporative dry eye (EDE), and mixed subtypes, DED presents with symptoms such as irritation, stinging, redness, foreign body sensation, sensitivity to light, and blurred or fluctuating vision. While rare, severe cases may lead to vision loss. With its rising global prevalence across age groups, DED poses a significant public health challenge. Primary care physicians (PCPs), often the first point of contact for DED patients, require timely screening and management strategies. This review explores the epidemiology, pathophysiology, clinical manifestations, diagnosis, and management of DED, emphasizing practical approaches for PCPs. This narrative review was conducted by searching MEDLINE, PubMed, and Google Scholar databases for relevant articles. Diagnostic approaches, including detailed history taking, patient-reported questionnaires, differential diagnosis, and assessments are discussed alongside management strategies, including symptomatic ophthalmic treatment, risk factor mitigation (e.g., reduced digital device screen time), prevention, and nutrition. By providing a synopsis of early symptoms that PCPs are often the first to encounter, practical approaches to screening and managing DED in the primary care setting, and guidelines on when to refer to specialty care, this comprehensive review aims to equip PCPs with the knowledge to improve DED screening and optimize patient outcomes.
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Affiliation(s)
- Jeonghyun Kwon
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
| | - Amirhossein Moghtader
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
| | - Christie Kang
- Department of Physiology and Biophysics, University of Illinois at Chicago, Chicago, IL 60612, USA;
| | - Zahra Bibak Bejandi
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
| | - Sumaiya Shahjahan
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
| | - Ahmad Alzein
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
| | - Ali R. Djalilian
- Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL 60612, USA; (J.K.); (A.M.); (Z.B.B.); (S.S.); (A.A.)
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14
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Ranđelović K, Jukić T, Tešija Kuna A, Sušić T, Hanžek M, Štajduhar A, Vatavuk Z, Petric Vicković I. Hashimoto's Thyroiditis and Dry Eye Disease. J Clin Med 2025; 14:1710. [PMID: 40095800 PMCID: PMC11900022 DOI: 10.3390/jcm14051710] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2025] [Revised: 02/20/2025] [Accepted: 03/01/2025] [Indexed: 03/19/2025] Open
Abstract
Hashimoto's thyroiditis (HT) is an autoimmune thyroid disease with characteristic lymphocytic infiltration and fibrosis. Chronic autoimmune changes that occur in the thyroid gland in HT may also affect the lacrimal gland. Objectives: This study aimed to analyze tear biomarkers and explore correlations between these biomarkers and clinical ocular parameters in patients with HT. Methods: A total of 150 participants were divided into three groups: HT (N = 50), non-HT DED (N = 50), and healthy controls (N = 50). The participants underwent a series of diagnostic tests for DED, including the Ocular Surface Disease Index, Tear Break-Up Time, Lid-Parallel Conjunctival Folds, Schirmer test without anesthetic, lissamine green and fluorescein staining. Tear samples were analyzed for cytokine and enzyme levels (interleukin 1β, tumor necrosis factor α, interleukin 6 (IL-6), interleukin 8, interleukin 10 (IL-10), interleukin 17A, matrix metalloproteinase 9 (MMP-9)) using ELISA and multiplex immunoassay. Statistical analyses were conducted to compare groups and assess biomarker correlations. Results: Dry eye disease was observed in more than half of the study group (27/50), with severe symptoms observed in 48.15% of the DED HT subgroup. IL-6 levels were significantly elevated in the DED HT subgroup compared to the non-HT DED group (p = 0.010), suggesting specificity for HT-associated DED. MMP-9 was elevated in both the HT and non-HT DED groups (p < 0.001) but lacked specificity for HT (p = 0.059). The DED HT subgroup exhibited significantly lower IL-10 levels (p = 0.008). Lissamine green staining and LIPCOF were significantly higher in the DED HT subgroup (p < 0.001). Conclusions: Dry eye disease is common in euthyroid HT patients without signs of TAO. This study highlights the potential role of IL-6. Lissamine green staining and LIPCOF are valuable diagnostic tools for assessing the ocular surface in DED HT patients.
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Affiliation(s)
- Karla Ranđelović
- Department of Ophthalmology, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (K.R.); (Z.V.)
- School of Dental Medicine, University of Zagreb, 10000 Zagreb, Croatia
| | - Tomislav Jukić
- Department of Oncology and Nuclear Medicine, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia;
| | - Andrea Tešija Kuna
- Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (A.T.K.); (T.S.); (M.H.)
| | - Tamara Sušić
- Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (A.T.K.); (T.S.); (M.H.)
| | - Milena Hanžek
- Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (A.T.K.); (T.S.); (M.H.)
| | - Andrija Štajduhar
- Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health “Andrija Štampar” and Medicine, University of Zagreb, 10000 Zagreb, Croatia;
| | - Zoran Vatavuk
- Department of Ophthalmology, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (K.R.); (Z.V.)
- School of Dental Medicine, University of Zagreb, 10000 Zagreb, Croatia
| | - Ivanka Petric Vicković
- Department of Ophthalmology, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia; (K.R.); (Z.V.)
- School of Dental Medicine, University of Zagreb, 10000 Zagreb, Croatia
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Jurkunas UV, Kaufman AR, Yin J, Ayala A, Maguire M, Samarakoon L, Johns LK, Parekh M, Li S, Gauthier A, Negre H, Shaw KL, Hernandez Rodriguez DE, Daley H, Dana R, Armant M, Ritz J. Cultivated autologous limbal epithelial cell (CALEC) transplantation for limbal tem cell deficiency: a phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the US. Nat Commun 2025; 16:1607. [PMID: 40038272 PMCID: PMC11880323 DOI: 10.1038/s41467-025-56461-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Accepted: 01/17/2025] [Indexed: 03/06/2025] Open
Abstract
We developed a two-stage manufacturing process utilizing cultivated autologous limbal epithelial cells (CALEC), the first xenobiotic-free, serum-free, antibiotic-free protocol developed in the United States, to treat blindness caused by unilateral limbal stem cell deficiency (LSCD) and conducted a single-center, single-arm, phase I/II clinical trial. Primary outcomes were feasibility (meeting release criteria) and safety (ocular infection, corneal perforation, or graft detachment). Participant eligibility included male or female participants age 18 to <90 years old and ability to provide written informed consent with LSCD. Funding was provided by the National Eye Institute of the National Institutes of Health. CALEC grafts met release criteria in 14 (93%) of 15 participants at conclusion of trial. After first stage manufacturing, intracellular adenosine triphosphate levels correlated with colony forming efficiency (r = 0.65, 95% CI [0.04, 0.89]). One bacterial infection occurred unrelated to treatment, with no other primary safety events. The secondary outcome was to investigate efficacy based on improvement in corneal epithelial surface integrity (complete success) or improvement in corneal vascularization and/or participant symptomatology as measured by OSDI and SANDI (partial success). 86%, 93%, and 92% of grafts resulted in complete or partial success at 3, 12, and 18 months, respectively. Our results provide strong support that CALEC transplantation is safe and feasible and further studies are needed to evaluate therapeutic efficacy. Clinicaltrials.gov registration: NCT02592330.
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Affiliation(s)
- Ula V Jurkunas
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.
| | - Aaron R Kaufman
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Jia Yin
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | | | | | | | - Lynette K Johns
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Mohit Parekh
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Sanming Li
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Alex Gauthier
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Helene Negre
- Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Kit L Shaw
- Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Diego E Hernandez Rodriguez
- Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Heather Daley
- Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, USA
| | - Reza Dana
- Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA
| | - Myriam Armant
- TransLab, Translational Research Program, Boston Children's Hospital, Boston, MA, USA
| | - Jerome Ritz
- Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, USA
- Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
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Feng Z, Yu K, Chen Y, Wang G, Deng Y, Wang W, Xu R, Zhang Y, Xiao P, Yuan J. Geometrical Features of Subbasal Corneal Whorl-like Nerve Patterns in Dry Eye Disease: An In Vivo Confocal Microscopy Study. OPHTHALMOLOGY SCIENCE 2025; 5:100669. [PMID: 39896423 PMCID: PMC11787521 DOI: 10.1016/j.xops.2024.100669] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/11/2024] [Revised: 11/03/2024] [Accepted: 12/02/2024] [Indexed: 02/04/2025]
Abstract
Purpose To investigate the geometrical feature of the whorl-like corneal nerve in dry eye disease (DED) across different severity levels and subtypes and preliminarily explore its diagnostic ability. Design Cross-sectional study. Participants The study included 29 healthy subjects (51 eyes) and 62 DED patients (95 eyes). Methods All subjects underwent comprehensive ophthalmic examinations, dry eye tests, and in vivo confocal microscopy to visualize the whorl-like corneal nerve at the inferior whorl (IW) region and the straight nerve at the central cornea. The structure of the corneal nerve was extracted and characterized using the fractal dimension (CNDf), multifractal dimension (CND0), tortuosity (CNTor), fiber length (CNFL), and numbers of branching points. Main Outcome Measures The characteristics of quantified whorl-like corneal nerve metrics in different groups of severity and subtype defined by symptoms and signs of DED. Results Compared with the healthy controls, the CNDf, CND0, and CNFL of the IW decreased significantly as early as grade 1 DED (P < 0.05), whereas CNTor increased (P < 0.05). These parameters did not change significantly in the straight nerve. As the DED severity increased, CNDf and CNFL in the whorl-like nerve further decreased in grade 3 DED compared with grade 1. Significant nerve fiber loss was observed in aqueous-deficient DED compared with evaporative DED (P < 0.05). Whorl-like nerve metrics correlated with ocular discomfort, tear film break-up time, tear secretion, and corneal fluorescein staining, respectively (P < 0.05). Furthermore, merging parameters of whorl-like and linear nerve showed an area under the curve value of 0.910 in diagnosing DED. Conclusions Geometrical parameters of IW could potentially allow optimization of the staging of DED. Reliable and objective measurements for the whorl-like cornea nerve might facilitate patient stratification and diagnosis of DED. Financial Disclosures Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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Affiliation(s)
- Ziqing Feng
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Kang Yu
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Yupei Chen
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Gengyuan Wang
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Yuqing Deng
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Wei Wang
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Ruiwen Xu
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Yimin Zhang
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Peng Xiao
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Jin Yuan
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-Sen University, Guangzhou, Guangdong, China
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Carro-Domínguez M, Huwiler S, Oberlin S, Oesch TL, Badii G, Lüthi A, Wenderoth N, Meissner SN, Lustenberger C. Pupil size reveals arousal level fluctuations in human sleep. Nat Commun 2025; 16:2070. [PMID: 40021662 PMCID: PMC11871316 DOI: 10.1038/s41467-025-57289-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2023] [Accepted: 02/18/2025] [Indexed: 03/03/2025] Open
Abstract
Recent animal research has revealed the intricate dynamics of arousal levels that are important for maintaining proper sleep resilience and memory consolidation. In humans, changes in arousal level are believed to be a determining characteristic of healthy and pathological sleep but tracking arousal level fluctuations has been methodologically challenging. Here we measured pupil size, an established indicator of arousal levels, by safely taping the right eye open during overnight sleep and tested whether pupil size affects cortical response to auditory stimulation. We show that pupil size dynamics change as a function of important sleep events across different temporal scales. In particular, our results show pupil size to be inversely related to the occurrence of sleep spindle clusters, a marker of sleep resilience. Additionally, we found pupil size prior to auditory stimulation to influence the evoked response, most notably in delta power, a marker of several restorative and regenerative functions of sleep. Recording pupil size dynamics provides insights into the interplay between arousal levels and sleep oscillations.
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Affiliation(s)
- Manuel Carro-Domínguez
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
| | - Stephanie Huwiler
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
| | - Stella Oberlin
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
| | - Timona Leandra Oesch
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
| | | | - Anita Lüthi
- Department of Fundamental Neurosciences, University of Lausanne, Lausanne, Switzerland
| | - Nicole Wenderoth
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
- Future Health Technologies, Singapore-ETH Center, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore, Singapore
- Neuroscience Center Zurich (ZNZ), University of Zurich, ETH Zurich, Zurich, Switzerland
| | - Sarah Nadine Meissner
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland
| | - Caroline Lustenberger
- Neural Control of Movement Lab, Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, 8092, Zurich, Switzerland.
- Neuroscience Center Zurich (ZNZ), University of Zurich, ETH Zurich, Zurich, Switzerland.
- Center of Competence Sleep & Health Zurich, University of Zurich, Zurich, Switzerland.
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Venugopal R, Sharma S, Singh L, Sen S, Velpandian T, Maharana PK, Kashyap S, Jain S, Sharma N. Topical low-dose heparin in ocular Stevens Johnson Syndrome and associated molecular correlations: a randomized controlled pilot study. Ocul Surf 2025:S1542-0124(25)00036-9. [PMID: 40024524 DOI: 10.1016/j.jtos.2025.02.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2024] [Revised: 02/22/2025] [Accepted: 02/28/2025] [Indexed: 03/04/2025]
Abstract
PURPOSE To elucidate the efficacy of topical low dose heparin (LDH) as an adjuvant therapy in of sub -chronic and chronic ocular Stevens-Johnson Syndrome (SJS) and its effect on Neutrophil extracellular traps (NETs) associated markers. DESIGN A prospective randomized controlled pilot trial METHODS: 72 clinically diagnosed SJS cases were recruited into sub-chronic and chronic groups. Both groups were randomly given either LDH eye drops with conservative treatment (CT) or CT alone for one month. Visual acuity, Schirmer's test, fluorescein and lissamine staining, OSDI score and ocular surface severity were evaluated. Tear and conjunctival cells were collected to detect NET-MPO complexes and NET-gene markers (TNFSF14, TLR9, IL-6, MyD88, C3a gene). MAIN OUTCOME MEASURES Improvement in ocular surface severity scores RESULTS: Sub-chronic group showed significant improvement with topical LDH in TBUT (p=0.0001), Lissamine stain score (p= 0.0162), corneal vascularisation score (p=0.0001), conjunctival hyperaemia score (p= 0.001) and total severity score (p= 0.001) when compared to the LDH treated chronic group. No significant improvement was seen in visual acuity in either group after one month of therapy. Qualitative ELISA confirmed higher presence of NET-MPO complex in sub-chronic cases. Both groups showed upregulation of TNFSF14, TLR9, and MyD88, which significantly decreased post topical LDH treatment (p =0.0038,0.002 and 0.043 respectively). CONCLUSION The presence of NETs mediated upregulated immune markers on sub-chronic and chronic SJS cases sheds newer light on its unresolved ocular pathology. Subsequent administration of topical LDH revealed a notable mitigation of NET associated immune markers, highlighting its promising anti-inflammatory effects within the ocular microenvironment.
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Affiliation(s)
- Renu Venugopal
- Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India
| | - Shivam Sharma
- Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India
| | - Lata Singh
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Seema Sen
- Department of Ocular Pathology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi
| | - Thirumurthy Velpandian
- Department of Ocular Pharmacology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi
| | - Prafulla Kumar Maharana
- Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India
| | - Seema Kashyap
- Department of Ocular Pathology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi
| | - Sandeep Jain
- Dry Eye & ocular GVHD Clinic, Department of Ophthalmology and Visual Science, University of Illinois, Chicago, Illinois, USA
| | - Namrata Sharma
- Cornea, Cataract & Refractive Surgery Services, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
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Navarro-Naranjo PI, Chacon-Aponte A, Artunduaga-Rodriguez G. Clinical Results of the Use of a Combined Solution of 0.5% Carboxymethylcellulose, 0.9% Glycerin, and 3% Trehalose for the Treatment of Dry Eye Disease. J Ocul Pharmacol Ther 2025. [PMID: 40014488 DOI: 10.1089/jop.2024.0115] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/01/2025] Open
Abstract
Objective: To describe the clinical effects of a novel, combined ocular lubricant for treating patients with dry eye disease. Methods: A noncomparative, retrospective cohort of 67 eyes (67 patients) with a confirmed diagnosis of dry eye disease using the ocular surface disease index (>12), tear osmolarity, and ocular surface parameters (noninvasive break-up time, meniscus height, and meibography) evaluated using the Cornea550 were included. All patients were treated with a combination of 0.5% carboxymethylcellulose, glycerin 0.9%, and trehalose 3% with a dosing regimen of one drop four times a day for 1 month with a final evaluation of the same parameters. Results: We included 67 eyes (80.6% females) with a mean age of 48.3 ± 16.2 years (standard deviation [SD]). In total, 37% of the subjects had comorbidities such as hypothyroidism (9%), ocular rosacea (4%), Sjogren's syndrome (4%), and arterial hypertension (4%). Of these, 34% were taking systemic medications and 56.7% had previous ocular surgery. The mean ocular surface disease index score before treatment was 57.6 ± 17.2 (SD) and 22.2 ± 12.9 points (SD) after treatment (P < 0.05). Other parameters such as noninvasive break-up time, meniscus height, and meibography improved without a statistically significant difference. Conclusion: Cristal Tears Plus is a novel, combined, and multipurpose treatment for dry eye disease.
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Affiliation(s)
- Pedro-Ivan Navarro-Naranjo
- Cornea and External Diseases, Asociacion Medica de Los Andes, Bogota, Colombia
- Master of Science in Epidemiology, Cornea and Refractive Surgery Service Asociacion Para Evitar La Ceguera (APEC), Mexico City, Mexico
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20
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Kim M, Lee CK, Shin J, Kim D, Rho S. Comparison of Efficacy and Ocular Surface Assessment Between Preserved and Preservative-Free Brimonidine/Timolol Fixed-Combination Eye Drops in Glaucoma Patients: A Parallel-Grouped, Randomized Trial. J Clin Med 2025; 14:1587. [PMID: 40095512 PMCID: PMC11900319 DOI: 10.3390/jcm14051587] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 02/12/2025] [Accepted: 02/24/2025] [Indexed: 03/19/2025] Open
Abstract
The objectives of the study were to compare the efficacy and safety using ocular surface assessment between preserved and preservative-free brimonidine/timolol fixed-combination eye drops in glaucoma or ocular hypertension patients. Methods: This study was designed as a prospective, multicenter (three institutions), investigator-masked, parallel-grouped randomized clinical trial. The primary outcomes were corneal and conjunctival staining score, ocular surface disease index (OSDI) score, drug tolerance, and adherence rates at 12-week visits. The secondary outcomes were corneal and conjunctival staining score, OSDI score at 4-week visits and intraocular pressure (IOP), tear-film break-up time (TBUT), and bulbar/limbal hyperemia score at the 4- and 12-week visits. For safety assessment, best-corrected visual acuity (BCVA), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and physical examination at 4 and 12 weeks and adverse events during the whole study period were analyzed. Results: Overall, 59 patients were enrolled and randomized into each group (29 preserved and 30 preservative-free). At the endpoint, 5 patients in the preserved group and 2 patients in the preservative-free group dropped out, leaving 24 and 28 patients in the preserved and preservative-free groups, respectively. Baseline characteristics showed no significant difference between the groups including age and sex. At the 12-week visit, intra-group change of OSDI scores did not change significantly compared to the baseline scores in both preserved and preservative-free groups (p = 0.791, 0.478, respectively). On the contrary, the corneal staining score and the conjunctival staining score showed a significant increase compared to the baseline score in the preserved group (p = 0.015, 0.009, respectively). Regarding drug satisfaction, higher proportions of patients in the preservative-free group reported convenience of installation (p = 0.002). Also, stinging and burning sensations in drug tolerance showed better results in the preservative-free group with a significant difference (p = 0.011). Safety assessment regarding systemic side effects such as SBP, DBP, and HR showed similar results between the preserved and preservative-free groups (p = 0.711, 0.232, 0.666, respectively). Conclusions: Preservative-free brimonidine/timolol showed comparable efficacy and safety, better corneal and conjunctival staining score with convenience of installation, and lower stinging and burning sensation. It is expected to be a proper treatment option for patients with glaucoma or ocular hypertension.
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Affiliation(s)
- Myungjin Kim
- Department of Ophthalmology, CHA Bundang Medical Center, CHA University, Seongnam 13496, Republic of Korea; (M.K.); (D.K.)
| | - Chang-Kyu Lee
- Department of Ophthalmology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan 44033, Republic of Korea;
| | - Jonghoon Shin
- Department of Ophthalmology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea;
- Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Republic of Korea
- PNU Busan Eye Clinic, Busan 46241, Republic of Korea
| | - Doah Kim
- Department of Ophthalmology, CHA Bundang Medical Center, CHA University, Seongnam 13496, Republic of Korea; (M.K.); (D.K.)
| | - Seungsoo Rho
- Department of Ophthalmology, CHA Bundang Medical Center, CHA University, Seongnam 13496, Republic of Korea; (M.K.); (D.K.)
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21
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Kandel H, Stapleton F, Downie LE, Chidi-Egboka NC, MIngo-Botin D, Arnalich-Montiel F, Rauz S, Recchioni A, Sitaula S, Markoulli M, Daien V, Babeau F, Geerling G, Craig JP, Watson SL. The impact of dry eye disease on patient-reported quality of life: A Save Sight Dry Eye Registry study. Ocul Surf 2025; 37:11-23. [PMID: 39954807 DOI: 10.1016/j.jtos.2025.02.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2024] [Revised: 01/23/2025] [Accepted: 02/11/2025] [Indexed: 02/17/2025]
Abstract
PURPOSE The aim of this real-world registry study was to evaluate the quality-of-life (QoL) impact of dry eye disease (DED). The specific objectives were to determine factors affecting QoL in DED, and to evaluate the psychometric properties of the Ocular Surface Disease Index (OSDI), Ocular Comfort Index (OCI), and Patient Health Questionnaire (PHQ) in a real-world DED population using modern psychometric methods. METHODS This descriptive cross-sectional study included 368 DED patients (mean 54.7 ± 16.6 years; 80.2 % female) who completed one or more of the three questionnaires (OSDI, OCI and PHQ). Psychometric analysis of the QoL data was carried out with Andrich's Rating Scale Model of Rasch analysis. RESULTS The original OSDI and OCI had disordered categories. The Rasch-optimised final QoL scales (OSDI - Overall, OSDI - Symptoms [SY], OSDI - Activity limitation [AL], OSDI - Environmental trigger [EN], OCI Overall, OCI - Frequency [FR], OCI - Intensity [IN], and PHQ) had satisfactory psychometric properties. Patients diagnosed with a mixed aqueous/evaporative DED subtype had worse mean OSDI-Overall and OSDI-AL scores than individuals with evaporative DED (p = 0.012 and 0.001 respectively). Patients with corneal neuropathic pain had worse QoL scores (OSDI-Overall, OSDI-AL, OSDI-SY, OSDI-EN, OCI-Overall, OCI-FR, OCI-IN, and PHQ; all p < 0.05) than those without. Patients who reported undergoing prior treatment or procedure for DED had worse QoL scores than those who did not (all p < 0.05 except for PHQ). The associations between DED signs (tear breakup time and staining) and symptoms were weak or not significant. CONCLUSIONS In this real-world setting, diagnoses of mixed DED, corneal neuropathic pain, and history of DED treatment/procedures were associated with worse dry eye symptoms, activity limitation, and/or QoL.
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Affiliation(s)
- Himal Kandel
- Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
| | - Fiona Stapleton
- School of Optometry and Vision Science, UNSW Sydney, New South Wales, Australia.
| | - Laura E Downie
- Department of Optometry and Vision Sciences, University of Melbourne, Melbourne, Victoria, Australia.
| | - Ngozi C Chidi-Egboka
- Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
| | | | | | - Saaeha Rauz
- Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, West Midlands, United Kingdom.
| | - Alberto Recchioni
- Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, West Midlands, United Kingdom.
| | - Sanjeeta Sitaula
- BP Koirala Lions Centre for Ophthalmic Studies, Institute of Medicine, Kathmandu, Nepal.
| | - Maria Markoulli
- School of Optometry and Vision Science, UNSW Sydney, New South Wales, Australia.
| | - Vincent Daien
- Ophthalmology, Centre Hospitalier Universitaire (CHU) Montpellier, Montpellier, France.
| | - Fanny Babeau
- Ophthalmology, Centre Hospitalier Universitaire (CHU) Montpellier, Montpellier, France.
| | - Gerd Geerling
- Ophthalmology, University Hospital Duesseldorf, Heinrich-Heine University, Duesseldorf, Germany.
| | - Jennifer P Craig
- Department of Ophthalmology, Aotearoa New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand.
| | - Stephanie L Watson
- Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
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22
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Locatelli EVT, Huang JJ, Betz JD, Huang JJ, Kantor NB, Reyes N, Felix ER, Lee WW, Galor A. Impact of botulinum toxin type A on ocular pain with neuropathic features. Ocul Surf 2025; 37:24-32. [PMID: 39952323 DOI: 10.1016/j.jtos.2025.02.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2024] [Revised: 01/07/2025] [Accepted: 02/11/2025] [Indexed: 02/17/2025]
Abstract
PURPOSE To investigate the impact of botulinum toxin type A (BoNT-A) on neuropathic/nociplastic ocular pain (NOP) and identify predictors of patient outcomes. METHODS A retrospective study of individuals with NOP symptoms (light sensitivity, wind/air sensitivity, persistent pain despite dry eye treatment) who received ≥1 BoNT-A injection. Primary outcome measures included if (responders vs. non-responders) and to what degree (none vs. mild vs. moderate vs. marked) individuals experienced pain improvement 4-6 weeks post-injection. Demographics and clinical exam information was compared between the groups. RESULTS 27 individuals received BoNT-A for NOP symptoms. 74 % (n = 20) reported an improvement in pain and were classified as responders. Among responders, the degree of benefit varied, with 25 % reporting mild, 45 % moderate, and 30 % marked pain improvement. Improvements in light sensitivity (37 %), wind/air sensitivity (33 %), and quality of life (QoL) (59 %) were reported by fewer individuals. 80 % of responders and 0 % of non-responders reported QoL improvements afer BoNT-A. In a multivariable model that examined predictors of response (none to marked, 0-3), the presence of fibromyalgia (FM) (β = 0.50; p = 0.004) portended a better response, while shooting pain (β = -0.47; p = 0.007) portended a worse response to BoNT-A, (full model r2 = 0.53; p < 0.001). Degree of pain improvement significantly correlated with improvements in light sensitivity, wind/air sensitivity, and QoL (ρ range: 0.42-0.63; p < 0.05). CONCLUSION After BoNT-A, most individuals reported improved ocular pain and QoL, while fewer noted improved light and wind/air sensitivity. Some systemic and ocular factors predicted treatment response and may thus guide treatment.
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Affiliation(s)
- Elyana V T Locatelli
- Surgical and Research Services, Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA; Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Jaxon J Huang
- Surgical and Research Services, Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA; Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Jason D Betz
- Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Jordan J Huang
- Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Nicole B Kantor
- Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Nicholas Reyes
- Surgical and Research Services, Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA; Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Elizabeth R Felix
- Surgical and Research Services, Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA
| | - Wendy W Lee
- Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA
| | - Anat Galor
- Surgical and Research Services, Miami Veterans Administration Medical Center, 1201 NW 16th St, Miami, FL, 33125, USA; Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL, 33136, USA.
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Hom MM, Ladhani O, Zhang Z, Liu H, Sonparote S, Dancey CC. Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms. CLINICAL OPTOMETRY 2025; 17:37-45. [PMID: 39963316 PMCID: PMC11830937 DOI: 10.2147/opto.s490732] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/14/2024] [Accepted: 01/22/2025] [Indexed: 02/20/2025]
Abstract
Purpose Dry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED. Methods This open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired t-test was performed to calculate P-values. Results A total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (P=0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (P=0.03) and -10.1 (10.6) points at 5 minutes post-dose (P<0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30. Conclusion Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.
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Ballesteros-Sánchez A, Tedesco GR, Rocha-de-Lossada C, Russo F, Sánchez-González JM, Borroni D. Efficacy and safety of a multi-action tear substitute based on 0.15% cross-linked hyaluronic acid, 3% trehalose and liposomes with stearylamine: A randomized, single-mask, controlled study. Graefes Arch Clin Exp Ophthalmol 2025:10.1007/s00417-025-06765-1. [PMID: 39934351 DOI: 10.1007/s00417-025-06765-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2024] [Revised: 01/16/2025] [Accepted: 01/30/2025] [Indexed: 02/13/2025] Open
Abstract
PURPOSE To evaluate the efficacy and safety of TriMix, a new multiple-action tear substitute in patients with dry eye disease (DED). METHODS This was a randomized, multicenter, single-masked, hyaluronic acid (HA)-controlled clinical trial conducted between July, 2023 and May, 2024. A total of 115 patients were randomly allocated to receive either TriMix tear substitute or 0.15% HA tear substitute 3 times daily. Clinical outcomes include ocular surface disease index (OSDI) questionnaire, non-invasive tear film break-up time (NIBUT) and Schirmer I test (ST) without anesthesia at 3 and 6 months of follow-up. RESULTS Of the 115 patients randomized, 80 completed the study (TriMix, n = 56; HA, n = 24). At months 3 and 6, improvements from baseline were statistically greater with TriMix tear substitute compared to HA 0.15% tear substitute for OSDI: -3.7 points (95% CI, -6.9 to -0.6; p = 0.011) and - 7.5 points (95% CI, -10.3 to -4.6; p < 0.001), respectively. Similar results were reported for NIBUT: 0.9 s (95% CI, 0.3 to 1.6; P = 0.040) and 1.6 s (95% CI, 0.7 to 2.6; P < 0.001), respectively. Regarding safety, no serious ocular adverse events occurred. Three patients complained of burning after instillation of TriMix tear substitute. CONCLUSION This RCTs demonstrate that TriMix tear substitute provides statistically significant and clinically evidence of the reduction of DED symptoms with a satisfactory safety profile through 6 months of follow-up. Findings suggest the use of this tear substitute, but results should be confirmed independently over longer time periods.
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Affiliation(s)
| | | | - Carlos Rocha-de-Lossada
- Qvision, Ophthalmology Department, VITHAS Almeria Hospital, 04120, Almeria, Spain
- Ophthalmology Department, VITHAS Malaga, 29016, Malaga, Spain
- Regional University Hospital of Malaga, Hospital Civil Square, 29009, Malaga, Spain
- Department of Surgery, Ophthalmology Area, University of Seville, 41009, Seville, Spain
| | - Fedele Russo
- Centro oculistico Russo, 339 castrovillari, Castrovillari, Italy
| | | | - Davide Borroni
- Riga Stradins University, LV-1007, Riga, Latvia
- Centro Oculistico Borroni, Gallarate, Italy
- Eyemetagenomics Ltd, 71-75, Shelton Street, Covent Garden, WC2H 9JQ, London, UK
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25
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Ramalho E, Soares I, Brardo FM, Nunes AF. Clinical validation of the Standardized Patient Evaluation of Eye Dryness Questionnaire in European Portuguese in a non-clinical sample. Int Ophthalmol 2025; 45:64. [PMID: 39920514 PMCID: PMC11805889 DOI: 10.1007/s10792-025-03437-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Accepted: 01/26/2025] [Indexed: 02/09/2025]
Abstract
INTRODUCTION The aim of this study is to determine the best cut-off value for the Standardized Patient Evaluation of Eye Dryness Portuguese version questionnaire and verify possible differences between the questionnaire score and different age groups. METHODS The clinical validation of the Standardized Patient Evaluation of Eye Dryness Portuguese version was performed by completing this and the Ocular Surface Disease Index in Portuguese version questionnaire, in 180 volunteers (68.9% female), with an age range of 19-96 years. RESULTS An excellent degree of reliability was found between the Standardized Patient Evaluation of Eye Dryness Portuguese version and the Ocular Surface Disease Index Portuguese version questionnaires (Cronbach's Alpha = 0.824). The Receiver Operating Characteristic curve analysis revealed a cut-off of 8 points (Sensitivity of 71.2% and Specificity of 71%). Furthermore, the area under the curve of the Receiver Operating Characteristic curve was 0.813, indicating that Standardized Patient Evaluation of Eye Dryness Portuguese version questionnaire is a good diagnostic tool and interchangeable with the Ocular Surface Disease Index questionnaire. CONCLUSION The Standardized Patient Evaluation of Eye Dryness Portuguese version questionnaire is a reliable tool for the detection of dry eye symptoms in the Portuguese population with a broad age range.
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Affiliation(s)
- Eva Ramalho
- University of Beira Interior, Covilhã, Portugal.
| | - Ivo Soares
- University of Beira Interior, Covilhã, Portugal
- Center for Research in Health Sciences (CICS), University of Beira Interior, Covilhã, Portugal
- Clinical and Experimental Center in Vision Sciences (CCECV), University of Beira Interior, Covilhã, Portugal
| | - Francisco Miguel Brardo
- University of Beira Interior, Covilhã, Portugal
- Center for Research in Health Sciences (CICS), University of Beira Interior, Covilhã, Portugal
- Clinical and Experimental Center in Vision Sciences (CCECV), University of Beira Interior, Covilhã, Portugal
| | - Amélia Fernandes Nunes
- University of Beira Interior, Covilhã, Portugal
- Center for Research in Health Sciences (CICS), University of Beira Interior, Covilhã, Portugal
- Clinical and Experimental Center in Vision Sciences (CCECV), University of Beira Interior, Covilhã, Portugal
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Mehta NN, Nagel ID, Agnihotri A, Heinke A, Cheng L, Bartsch DU, Freeman WR, Gomez ML. Dry eye disease treatment improves subjective quality-of-life responses in patients with AMD, independent of disease stage. PLoS One 2025; 20:e0318733. [PMID: 39913504 PMCID: PMC11801640 DOI: 10.1371/journal.pone.0318733] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Accepted: 01/21/2025] [Indexed: 02/09/2025] Open
Abstract
PURPOSE To determine the impact of severity of age-related macular degeneration (AMD) on subjective treatment response in patients treated for dry eye disease. METHODS A total of 203 eyes diagnosed with evaporative dry eye disease (DED) due to meibomian gland dysfunction were treated using the LipiFlow or MiBoFlo systems. From this cohort, 40 eyes with stable dry AMD (early, intermediate, or late stages) were included. Each participant completed the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) before treatment and at a 6-month follow-up. Changes in questionnaire scores were analyzed using one-way analysis of variance (ANOVA) to assess differences between AMD severity groups. RESULTS Improvement in SPEED and OSDI scores, including vision related OSDI scores were observed across all AMD stages, with no significant differences between groups (p<0.05). CONCLUSION Managing DED improved quality of life (QOL) in patients with AMD, regardless of retinal disease severity. This highlights the importance of treating coexisting ocular surface conditions to enhance patient outcomes, even in the presence of significant maculopathy.
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Affiliation(s)
- Nehal Nailesh Mehta
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Ines D. Nagel
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Akshay Agnihotri
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Anna Heinke
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
- Division of Ophthalmology Informatics and Data Science, Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Lingyun Cheng
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Dirk-Uwe Bartsch
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - William R. Freeman
- Jacobs Retina Center, La Jolla, California, United States of America
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
| | - Maria-Laura Gomez
- Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California, United States of America
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Utheim TP, Chen X, Fineide F, Steinkjer T, Heegaard S, Kolko M, Dartt DA, Khan AZ. Response predictors of a topical corticosteroid-based regimen for dry eyes: A real-life study. Acta Ophthalmol 2025; 103:93-98. [PMID: 39344883 PMCID: PMC11704838 DOI: 10.1111/aos.16758] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Accepted: 09/14/2024] [Indexed: 10/01/2024]
Abstract
PURPOSE To examine the effectiveness and identify clinical response predictors of a short corticosteroid-based regimen consisting of topical preservative-free 0.1% dexamethasone (Monopex®, Théa Laboratories) in conjunction with artificial tears (AT) for dry eyes in a real-life clinical setting. METHODS Patients were recruited from the Norwegian Dry Eye Clinic and were allowed to use ATs of their own choice in addition to the prescribed 14-day topical dexamethasone course. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire (DEQ-5), Schirmer test (ST), fluorescein tear film break-up time (FBUT), ocular surface staining (OSS), meibum expressibility (ME), meibum quality (MQ), number of expressible meibomian glands among the central eight glands in the lower lids (NMG) and intraocular pressure (IOP) were measured at baseline and at 1-month follow-up. The average values of clinical parameters from both eyes were used for analyses. A paired t-test and a significance value of p < 0.05 were used for statistical analyses. Associations between sex, age, baseline values and the changes after the intervention (Δ) were explored using linear regression. RESULTS A total of 167 patients (124 women, mean age 54 years ±17 (standard deviation)) were included. One month after initiation of intervention, OSDI and DEQ5 scores improved from 39.5 ± 22.1 to 31.4 ± 21.3 (p < 0.001) and from 12.6 ± 4.2 to 11.0 ± 4.6 (p < 0.001), respectively. OSS improved from 2.2 ± 1.4 to 1.8 ± 1.5 (p < 0.001), NMG increased from 4.8 ± 2.2 to 5.1 ± 2.2 (p < 0.05), while IOP decreased from 12.9 ± 3.3 to 12.4 ± 3.5 mmHg (p < 0.05). Significant associations were found between the change in symptoms and objective measures of DED (ΔOSDI, ΔDEQ5, ΔOSS, ΔFBUT, ΔNMG, ΔMQ) and their respective baseline values (OSDI, DEQ5, OSS, FBUT, NMG, MQ). The remaining tests did not show statistically significant changes. CONCLUSION Improvement in dry eye symptoms and signs were observed following a short course of topical, preservative-free 0.1% dexamethasone treatment in combination with AT. Individuals exhibiting more pronounced symptoms and signs witnessed the most profound improvements with the treatment regimen, suggesting that poor baseline parameters may serve as response predictors of the treatment regimen. While the real-life data presented herein are valuable, the conclusions are limited by the inherent biases of a non-controlled study.
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Affiliation(s)
- Tor Paaske Utheim
- Department of Medical BiochemistryOslo University HospitalOsloNorway
- The Norwegian Dry Eye ClinicOsloNorway
- Department of OphthalmologyØstfold Hospital TrustMossNorway
- Department of Ophthalmology, Drammen HospitalVestre Viken TrustDrammenNorway
- Department of OphthalmologyOslo University HospitalOsloNorway
- Department of OphthalmologySørlandet Hospital ArendalArendalNorway
- Department of OphthalmologyStavanger University HospitalStavangerNorway
- Department of OphthalmologyVestfold Hospital TrustTønsbergNorway
- Department of Plastic and Reconstructive SurgeryOslo University HospitalOsloNorway
- Department of Clinical Medicine, Faculty of MedicineUniversity of BergenBergenNorway
- Department of Research and DevelopmentOslo Metropolitan UniversityOsloNorway
- Department of Oral Biology, Faculty of DentistryUniversity of OsloOsloNorway
- Department of Quality and Health Technology, The Faculty of Health SciencesUniversity of StavangerStavangerNorway
- Department of Health and Nursing Science, The Faculty of Health and Sport SciencesUniversity of AgderGrimstadNorway
- National Centre for Optics, Vision and Eye Care, Department of Optometry, Radiography and Lighting Design, Faculty of Health SciencesUniversity of South‐Eastern NorwayKongsbergNorway
- Department of Ophthalmology, Faculty of Life Course Sciences and MedicineKing's College LondonLondonUK
- Department of Computer ScienceOslo Metropolitan UniversityOsloNorway
- Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Department of OphthalmologyHarvard Medical SchoolBostonMassachusettsUSA
| | - Xiangjun Chen
- Department of Medical BiochemistryOslo University HospitalOsloNorway
- The Norwegian Dry Eye ClinicOsloNorway
- Department of Ophthalmology, Drammen HospitalVestre Viken TrustDrammenNorway
- Department of OphthalmologySørlandet Hospital ArendalArendalNorway
| | - Fredrik Fineide
- Department of Medical BiochemistryOslo University HospitalOsloNorway
- The Norwegian Dry Eye ClinicOsloNorway
| | - Tore Steinkjer
- The Norwegian Dry Eye ClinicOsloNorway
- Department of Plastic and Reconstructive SurgeryOslo University HospitalOsloNorway
| | - Steffen Heegaard
- Department of OphthalmologyCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
| | - Miriam Kolko
- Department of OphthalmologyCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
| | - Darlene A. Dartt
- Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Department of OphthalmologyHarvard Medical SchoolBostonMassachusettsUSA
| | - Ayyad Zartasht Khan
- Department of Medical BiochemistryOslo University HospitalOsloNorway
- The Norwegian Dry Eye ClinicOsloNorway
- Department of OphthalmologyØstfold Hospital TrustMossNorway
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Zhao CS, Chen Y, Yu Y, Ying GS, Asbell PA. Longitudinal Analysis of Tear Cytokine Ratios in Association with Dry Eye Signs and Symptoms in the Dry Eye Assessment and Management (DREAM) Study. Curr Eye Res 2025; 50:124-131. [PMID: 39267294 PMCID: PMC11774680 DOI: 10.1080/02713683.2024.2398113] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Revised: 08/09/2024] [Accepted: 08/23/2024] [Indexed: 09/17/2024]
Abstract
PURPOSE To extend cross-sectional data on cytokine ratios (CRs) in dry eye disease (DED) signs by investigating longitudinal change in pro- to anti-inflammatory CRs and associations with change in DED signs and symptoms. METHODS Secondary analysis of fifty-four subjects [mean age 57.3 (SD 13.2) years, 85.2% female; 68.5% white] with ≥ 4 uL pooled tear volumes at months 0, 6, and 12. Pro-inflammatory (IL-1b, IL-6, IL-8, IL-17A, IFN-g, and TNF-a) to anti-inflammatory (IL-6, IL-10) cytokine ratios (CR) were calculated. DED signs (corneal and conjunctival staining scores, tear break-up time, Schirmer test, Meibomian gland plugging, tear osmolarity, composite sign severity score) and symptoms [Ocular Surface Disease Index (OSDI)] were measured. Changes over time in DED signs, symptoms, and CRs were evaluated using longitudinal models. Correlations between changes in CR and changes in DED signs and symptoms were evaluated using Spearman correlation coefficients (rho). RESULTS DED signs which improved over time (p < 0.001) included corneal and conjunctival staining score, tear break-up time, tear osmolarity, and composite sign severity score. Using IL-10 as anti-inflammatory, changes in corneal and conjunctival staining and composite severity score significantly correlated with changes in pro- to anti-inflammatory CRs from month 0 to 6 (|rho|: 0.29-0.45, p: 0.003-0.04) but not between month 0 to 12 (|rho|: 0.01 to 0.24, all p > 0.08). DED symptoms decreased across one year (p < = 0.001) for all OSDI measures; these changes did not correlate with changes in CRs (|rho|: 0.00 to 0.29, all p > 0.04). CONCLUSIONS Improvement in some DED signs across one year correlated weakly with decreases in pro- to anti-inflammatory CRs, in alignment with the understanding of DED as inflammatory. CRs may provide greater insight than absolute tear cytokine concentrations as possible DED biomarkers. Additional studies that provide standardized clinical information and tear collection and analysis are needed to validate CRs in DED.
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Affiliation(s)
- Cindy S. Zhao
- Department of Ophthalmology, Stanford Byers Eye Institute, Palo Alto, CA, USA
| | - Yineng Chen
- Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Yinxi Yu
- Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Gui-Shuang Ying
- Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Penny A. Asbell
- Department of Bioengineering, University of Memphis, Memphis, TN, USA
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Liang R, Li N, Liu L, Du B, Pazo E, Wei R. Scleral Contact Lens Benefits for Myopic Patients With Regular Corneas: A Prospective Randomized Study. Eye Contact Lens 2025; 51:76-84. [PMID: 39773951 DOI: 10.1097/icl.0000000000001151] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/13/2024] [Indexed: 01/11/2025]
Abstract
OBJECTIVES To evaluate the impact of scleral contact lens (SL) wear on the visual quality and the ocular surface wettability in myopic patients with regular corneas. METHODS This prospective, randomized, controlled study enrolled a total of 80 myopes with regular corneas. Subjects were randomly allocated to wear SL or rigid corneal lens (RCL) for 3 months. The objective optical quality parameters were detected using the Optical Quality Analysis System-II, and the ocular surface wettability was assessed using the Keratograph 5M noninvasive ocular surface analyzer. The National Eye Institute 25-Item Visual Function Questionnaire and Ocular Surface Disease Index questionnaire were performed. RESULTS Both SL and RCL wear could obtain good best-corrected visual acuity. Strehl ratio, modulation transfer function cutoff frequency, objective scattering index, and Optical Quality Analysis System values (Optical Quality Analysis System values at 100%, 20%, and 9% contrasts) in the SL group significantly improved from baseline to the third month (both P <0.05), but not in the RCL group. At the third month, tear meniscus height and noninvasive tear break-up time showed a significant increase in the SL wearers from baseline (both P <0.05), but exhibited no significant changes in the RCL group. At the third month, SL wearers had significantly higher noninvasive tear break-up time compared with RCL wearers ( P <0.05). Besides, after 3-month SL wear, the National Eye Institute 25-Item Visual Function Questionnaire score and the Ocular Surface Disease Index score both remarkably improved from baseline (both P <0.05). CONCLUSION Short-term SL wear could provide satisfactory visual quality, ocular comfort, and stable tear film for myopic patients.
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Affiliation(s)
- Ruixue Liang
- Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, China
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Rivoal Y, Miguel A, Bailleul H, Canino M, Bacon S, Saint-Lorant G, Deloison É, Quintyn JC. Study of quality of life in patients treated with autologous serum eye drops. J Fr Ophtalmol 2025; 48:104373. [PMID: 39662310 DOI: 10.1016/j.jfo.2024.104373] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/10/2023] [Revised: 09/06/2024] [Accepted: 09/17/2024] [Indexed: 12/13/2024]
Abstract
Dry eye syndrome is a multifactorial disease with a complex pathophysiology. The associated morbidity is a worldwide public health problem. The development of autologous serum-based eye drops is an interesting treatment but presents some constraints. This is a retrospective, observational, single-center study of 43 patients (73 eyes) treated with autologous serum-based eye drops for dry eye syndrome at the University Hospital of Caen between 2014 and 2023. The patients' subjective symptoms, as well as the various modalities of evaluation of their daily quality of life were collected using questionnaires inspired by the OSDI questionnaire. The other elements used in this study were reported from the patients' medical files. We observed a mean improvement in quality of life of 44% in the treated subjects. Quality of life correlates with the improvement in the subject's quality of life score and overall health (P<0.01) but, nevertheless, depends on the severity of the initial clinical damage and the presence or absence of a corneal ulcer (P=0.013). We also found a reduction in the number of daily drops (65.4%) and an improvement in daily activities (85.1%). This study's results are consistent with previous work reporting the efficacy of autologous serum on the quality of life of treated patients. Consideration of the patient as a whole, integrating quality of life assessment with clinical examination, is essential when dealing with dry eye and its innovative therapeutics.
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Affiliation(s)
- Y Rivoal
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France.
| | - A Miguel
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
| | - H Bailleul
- Hôpital Privé de la Baie, 1, avenue du Quesnoy, 50300 Avranches, France
| | - M Canino
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
| | - S Bacon
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
| | - G Saint-Lorant
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
| | - É Deloison
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
| | - J-C Quintyn
- University Hospital of Caen, avenue de la Côte de Nacre, 14000 Caen, France
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Sabarwal S, Priyanka, Moharana B, Gupta R, Sharma B. Prevalence, Pattern and Associated Risk Factors of Dry Eye Disease From a Prospective Database of a Tertiary Eye Care Centre in Central India. Cureus 2025; 17:e78889. [PMID: 40099097 PMCID: PMC11911549 DOI: 10.7759/cureus.78889] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/12/2025] [Indexed: 03/19/2025] Open
Abstract
Purpose This study aimed to assess the prevalence, pattern and associated risk factors with dry eye disease (DED) at a tertiary eye care centre in Central India. Methods This prospective cross-sectional study, conducted over 48 months, enrolled patients with systematic random sampling. Evaluation of DED was done with subjective and objective methods comprising of the Ocular Surface Disease Index (OSDI) questionnaire, slit lamp examination, Schirmer's tests and fluorescein tear-film breakup time (FTBUT) test. Patients were categorised into mild, moderate, severe and very severe DED. Association with various etiological factors like age, sex, occupation, diabetes mellitus, autoimmune disorders and any other systemic illness was assessed. The chi-square test/Fischer's exact test was used to analyse categorical data. Bivariate logistic regression analysis was used to calculate the odds ratio (OR). Multivariate analysis was performed to identify independent risk factors. Results A total of 2,560 patients were evaluated, of which 640 patients (25%) had DED. Prevalence was higher in patients aged >50 years, household workers, students, government employees and farmers. Uncorrected refractive status, cigarette smoking, ocular allergy and contact lens usage were associated with increasing odds of developing DED. Conclusion The prevalence of DED was estimated to be 25% in central India. Certain occupations like household workers, students, government employees, farmers, uncorrected refractive status, cigarette smoking, ocular allergy and contact lens use were significant risk factors for dry eyes.
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Affiliation(s)
- Sunita Sabarwal
- Ophthalmology, All India Institute of Medical Sciences, Bhopal, Bhopal, IND
| | - Priyanka
- Ophthalmology, All India Institute of Medical Sciences, Bhopal, Bhopal, IND
| | - Bruttendu Moharana
- Ophthalmology, All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, IND
| | - Rituka Gupta
- Ophthalmology, All India Institute of Medical Sciences, Bhopal, Bhopal, IND
| | - Bhavana Sharma
- Ophthalmology, All India Institute of Medical Sciences, Bhopal, Bhopal, IND
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Macedo-de-Araújo RJ, Amorim-de-Sousa A, González-Méijome JM. Influence of midday removal and re-application of a scleral lens on fluid reservoir thickness, pre-lens tear film quality and visual acuity. Cont Lens Anterior Eye 2025; 48:102250. [PMID: 38897843 DOI: 10.1016/j.clae.2024.102250] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2024] [Revised: 05/13/2024] [Accepted: 06/05/2024] [Indexed: 06/21/2024]
Abstract
PURPOSE To investigate whether the midday removal and re-application of scleral lenses (SL) influences fluid reservoir (FR) thickness, pre-lens tear film quality and visual acuity. METHODS Two clinical experiments were conducted. A total of 49 keratoconic eyes were evaluated for Part1(tear film and visual acuity analysis) and 12 keratoconic eyes for Part2 (FR thickness analysis). All subjects were wearing 16.4 mm SL for more than 12-months. Tear Film Surface Quality (TFSQ) was evaluated with Medmont E300 at more than 120 min of SL wear, 10 min after SL removal (pre-corneal TFSQ) and 5 min after re-apply the same SL. High and Low Contrast Visual Acuity (HCVA and LCVA) were also assessed with the SL on eye (before and after re-application). For Part2, Anterior OCT (MOptim MOcean4000, China) measurements were taken with and without the SL (at the same time points of Part1) and three outcomes were evaluated: FR thickness, SL thickness (control measurement) and corneal thickness. RESULTS Removing and re-applying a SL had a statistically significant positive impact on TFSQ, with an improvement from 0.26 ± 011 to 0.16 ± 0.08 (p = 0.001). This was accompanied by a statistically significant improvement in LogMAR HCVA (from 0.10 ± 0.09 to 0.08 ± 0.08, p < 0.001) and LCVA (from 0.39 ± 0.13 to 0.36 ± 0.13, p < 0.001). Regarding Part2 of the study, a statistically significant increase in FR thickness was observed after SL re-application (from 223.64 ± 48.08 µm to 267.81 ± 80.03 µm, p = 0.007). No changes in corneal thickness were observed. CONCLUSIONS Midday removal and re-application of a scleral lens positively impacted pre-lens tear film surface quality, although the observed improvement in visual acuity does not constitute a clinically significant change. Clinicians should consider that removing and reapplying a scleral lens may result in an overestimation of the fluid reservoir thickness, which could affect clinical assessments and treatment decisions.
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Affiliation(s)
- Rute J Macedo-de-Araújo
- Clinical & Experimental Optometry Research Lab (CEORLab), University of Minho, Braga, Portugal; Physics Center of Minho and Porto Universities (CF-UM-UP), University of Minho, Braga, Portugal.
| | - Ana Amorim-de-Sousa
- Clinical & Experimental Optometry Research Lab (CEORLab), University of Minho, Braga, Portugal; Physics Center of Minho and Porto Universities (CF-UM-UP), University of Minho, Braga, Portugal
| | - José M González-Méijome
- Clinical & Experimental Optometry Research Lab (CEORLab), University of Minho, Braga, Portugal; Physics Center of Minho and Porto Universities (CF-UM-UP), University of Minho, Braga, Portugal
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Feng C, Wang W, Gong L, Lin T. Efficacy of Topical Cyclosporine Combined with Punctal Plugs in Treating Dry Eye Disease and Inflammation. Curr Eye Res 2025; 50:148-161. [PMID: 39373208 DOI: 10.1080/02713683.2024.2411699] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2024] [Revised: 09/13/2024] [Accepted: 09/26/2024] [Indexed: 10/08/2024]
Abstract
PURPOSE To evaluate the effect of punctal plugs combined with cyclosporine eye drops on dry eye disease (DED) and ocular surface inflammation. METHODS In a clinical trial, 73 patients were randomly allocated into three groups: punctal plug group, combination therapy group, and cyclosporine group. At the baseline and four weeks after treatment, the Schirmer I test score, fluorescein tear film break-up time (FBUT), ocular surface staining score and dry eye symptoms were assessed. Tear samples were collected to detect the level of inflammatory factors (interleukins, matrix metalloproteinase 9 (MMP-9) and tumor necrosis factor alpha (TNF-α)). In an animal experiment, a New Zealand rabbit dry eye model was induced. The rabbits were randomly divided into control group, punctal plug group, and combination therapy group (n = 6). Conjunctival goblet cell density, protein level of MMP-9 in conjunctiva and mRNA levels of inflammatory factors in conjunctiva and cornea were measured before and after treatment. RESULTS In combination therapy group of the clinical trial, the following results were observed: significant improvement in Schirmer I test scores and FBUT compared to the cyclosporine group and punctal plug group, respectively; a decrease in the tear levels of IL-6, IL-1, and MMP-9 compared to the punctal plug group; and a decrease in the tear levels of IL-1α, IL-6, and IL-17 compared to the baseline (all p < 0.05). In the animal experiment, rabbits in combination therapy group had a higher goblet cell density (p < 0.01) and lower mRNA levels of IL-16 (p < 0.05), IL-17 (p < 0.05), and MMP-9 (p < 0.01) in conjunctiva and that of MMP-9 (p < 0.01) in cornea compared to punctal plug group. CONCLUSION Cyclosporine eye drops combined with degradable punctal plugs is a more optimized clinical treatment strategy for DED compared with degradable punctal plugs or cyclosporine eye drops alone, considering the influence of comprehensive clinical efficacy and ocular surface inflammation.
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Affiliation(s)
- Changming Feng
- Department of Ophthalmology, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China
- NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China
- Shanghai Key Laboratory of Visual Impairment and Restoration, Fudan University, Shanghai, China
| | - Wushuang Wang
- Department of Ophthalmology, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China
- NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China
- Shanghai Key Laboratory of Visual Impairment and Restoration, Fudan University, Shanghai, China
| | - Lan Gong
- Department of Ophthalmology, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China
- NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China
- Shanghai Key Laboratory of Visual Impairment and Restoration, Fudan University, Shanghai, China
| | - Tong Lin
- Department of Ophthalmology, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China
- NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China
- Shanghai Key Laboratory of Visual Impairment and Restoration, Fudan University, Shanghai, China
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Unlu M, Ozer F, Sahin Aslan E, Sener H, Erkilic K. Can the combination of citicoline and vitamin B12 be beneficial in the healing of corneal nerves after corneal cross-linking? Int Ophthalmol 2025; 45:54. [PMID: 39890769 DOI: 10.1007/s10792-025-03433-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2024] [Accepted: 01/21/2025] [Indexed: 02/03/2025]
Abstract
PURPOSE To evaluate the effect of topical citicoline, vitamin B12 and hyaluronic acid (OMK2 eye drops; Omikron Italia Srl, Italy) on the healing of corneal nerve after corneal cross-linking (CXL) treatment in patients with keratoconus (KC). METHODS A total of 44 eyes of 22 patients with KC who underwent CXL were included in this prospective study. After CXL, one eye of these patients received OMK2 eye drop and standard post-CXL treatment (OMK2 group), while the fellow eye received only standard post-CXL treatment (control group). The following parameters were analyzed in the pre- and post-CXL procedure periods (1st, 3rd and 6th months): corneal sensitivity, tear film stability, central corneal thickness (CCT), and the corneal sub-basal nerve plexus (sbNP) parameters (including corneal nerve fiber density [CNFD], corneal nerve branch density [CNBD], corneal nerve fiber length [CNFL], corneal total branch density [CTBD], corneal nerve fiber area [CNFA], corneal nerve fiber width [CNFW]). RESULTS Following CXL, a comparison of the baseline and month 6 data revealed that CNFA decreased in the control group (p < 0.001) and did not differ in the OMK2 group (p = 0.283). Other corneal sbNP parameters exhibited a decrease when comparing baseline and 6 months in each group (all p < 0.05). In addition, CCT in the OMK2 group was not significantly different between baseline and month 6 (p = 0.052). However, a decline in CCT of the control groups was observed during this specified time interval (p = 0.009). Corneal sensitivity or tear film stability parameters did not differ significantly between groups at any time point or over time within each group (all p > 0.05). CONCLUSION The use of OMK2 eye drop after CXL may provide more stable CNFA. In addition, it may also provide faster recovery in CCT.
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Affiliation(s)
- Metin Unlu
- Department of Ophthalmology, Division of Cornea, Erciyes University Medical Faculty, Kayseri, Turkey
| | - Furkan Ozer
- Department of Ophthalmology, Sungurlu State Hospital, Çorum, Turkey
| | - Esra Sahin Aslan
- Department of Ophthalmology, Division of Cornea, Erciyes University Medical Faculty, Kayseri, Turkey
| | - Hidayet Sener
- Department of Ophthalmology, Division of Cornea, Erciyes University Medical Faculty, Kayseri, Turkey
| | - Kuddusi Erkilic
- Department of Ophthalmology, Division of Cornea, Erciyes University Medical Faculty, Kayseri, Turkey
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Galor A, Gallar J, Acosta MC, Meseguer V, Benítez-Del-Castillo JM, Stachs O, Szentmáry N, Versura P, Müller-Lierheim WGK, Belmonte C, Pujol-Martí J. CORONIS symposium 2023: Scientific and clinical frontiers in ocular surface innervation. Acta Ophthalmol 2025. [PMID: 39891368 DOI: 10.1111/aos.17450] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Accepted: 01/19/2025] [Indexed: 02/03/2025]
Abstract
The 5th CORONIS Symposium, held during the 2023 Congress of the European Association for Vision and Eye Research (EVER), highlighted the growing importance of ocular surface innervation in eye surface disorders. This article summarises the insights and perspectives shared during the symposium, which focused on the clinical relevance of ocular surface innervation, as well as on the development of innovative diagnostic and therapeutic approaches for ocular surface pathologies linked to disturbed sensory innervation. Through robust interdisciplinary collaborations, these developments hold great potential to improve patient outcomes and quality of life.
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Affiliation(s)
- Anat Galor
- Department of Ophthalmology, Miami Veterans Affairs Medical Center, Miami, Florida, USA
- Bascom Palmer Eye Institute, University of Miami, Miami, Florida, USA
| | - Juana Gallar
- Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain
- Instituto de Investigación Sanitaria y Biomédica de Alicante, Alicante, Spain
| | - M Carmen Acosta
- Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain
| | - Víctor Meseguer
- Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain
| | | | - Oliver Stachs
- Klinik und Poliklinik für Augenheilkunde, Universitätsmedizin Rostock, Rostock, Germany
- Interdisziplinäre Fakultät Leben, Licht & Materie, Universität Rostock, Rostock, Germany
| | - Nóra Szentmáry
- Dr Rolf M. Schwiete Center for Limbal Stem Cell and Congenital Aniridia Research, Saarland University, Homburg, Germany
- Department of Ophthalmology, Semmelweis University, Budapest, Hungary
| | - Piera Versura
- Ophthalmology Unit, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Alma Mater Studiorum Università di Bologna, Bologna, Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
| | | | - Carlos Belmonte
- Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain
| | - Jesús Pujol-Martí
- i.com medical GmbH, Munich, Germany
- CORONIS FOUNDATION, Munich, Germany
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Lu C, Han D, Zeng L, Hong J, Fadel D, Zhou X, Chen Z, Le Q. Short-Term Efficacy and Safety of Scleral Lenses in the Management of Severe Dry Eye in a Chinese Population. J Clin Med 2025; 14:658. [PMID: 39941328 PMCID: PMC11818766 DOI: 10.3390/jcm14030658] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2024] [Revised: 12/17/2024] [Accepted: 01/17/2025] [Indexed: 02/16/2025] Open
Abstract
Background: Scleral lenses (SLs) are recommended in DEWS II to treat dry eye (DE) patients that do not respond well to conventional therapies. This study aimed to evaluate the short-term (one month) efficacy and safety of SLs in the management of severe DE. Methods: This single-center prospective study enrolled 15 patients (22 eyes) who were diagnosed with severe DE. The Ocular Surface Disease Index (OSDI), the Chinese version of the 25-item National Eye Institute Visual Function Questionnaire (CHI-VFQ-25), and LogMAR best-corrected visual acuity (BCVA) were evaluated at baseline and one month following SL fitting. DE-related parameters were obtained and analyzed before and after one month of SL treatment, including tear-film breakup time (TBUT), corneal fluorescein staining (CFS), non-invasive breakup time (NIBUT), tear meniscus height (TMH), Schirmer I test (SIT), and meibomian gland (MG) dropout. Complications and adverse events were monitored. Results: OSDI scores (53.9 ± 28.1 vs. 10.4 (4.2-25), p = 0.0001) and CFS scores (10.2 ± 3.9 vs. 7 (0-12), p = 0.001) decreased after one month of SL therapy, while CHI-VFQ-25 scores (74.4 (54.8-83.8) vs. 95 (78.7-98), p = 0.0001) and TBUT (0.6 ± 0.5 vs. 2.2 ± 1.0, p < 0.0001) increased significantly. LogMAR BCVA improved from 0 (0-0.1) to 0 (0-0) (p = 0.0147). The average types of medications per eye decreased from 2.82 ± 1.01 to 1.32 ± 0.64 (p = 0.025), and the proportion of eyes using glucocorticoids significantly decreased from 63.6% to 13.6% (p = 0.001). No severe SL-related adverse events were reported. Conclusions: SL treatment quickly alleviated subjective symptoms as well as clinical signs of DE with good safety and enhanced the visual function and vision-related quality of life, showing its usefulness in the management of severe DE.
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Affiliation(s)
- Chuwei Lu
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
| | - Danjie Han
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
| | - Li Zeng
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
- NHC Key laboratory of Myopia and Related Eye Diseases, Shanghai 200031, China
- Shanghai Engineering Research Center of Synthetic Immunology, Shanghai 200032, China
| | - Jiaxu Hong
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
- NHC Key laboratory of Myopia and Related Eye Diseases, Shanghai 200031, China
- Shanghai Engineering Research Center of Synthetic Immunology, Shanghai 200032, China
- Department of Ophthalmology, Children’s Hospital of Fudan University, National Pediatric Medical Center of China, Shanghai 201102, China
| | - Daddi Fadel
- Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo, Waterloo, ON N2L 3G1, Canada;
| | - Xingtao Zhou
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
- NHC Key laboratory of Myopia and Related Eye Diseases, Shanghai 200031, China
- Shanghai Engineering Research Center of Synthetic Immunology, Shanghai 200032, China
| | - Zhi Chen
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
- NHC Key laboratory of Myopia and Related Eye Diseases, Shanghai 200031, China
| | - Qihua Le
- Department of Ophthalmology, Eye, Ear, Nose & Throat Hospital of Fudan University, Shanghai 200031, China; (C.L.); (D.H.); (L.Z.); (J.H.); (X.Z.)
- NHC Key laboratory of Myopia and Related Eye Diseases, Shanghai 200031, China
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Mohamed-Noriega K, Riega-Torres J, Ramírez-Paura AN, Martínez-Delgado JF, Álvarez-González OE, Velasco-Sepúlveda BH, Morales-Wong F, Garza-Elizondo MA, Galarza-Delgado DÁ, Mohamed-Hamsho J. Is There a Difference Between Seropositive and Seronegative Sjögren Disease Dry Eye? Cornea 2025:00003226-990000000-00797. [PMID: 39836525 DOI: 10.1097/ico.0000000000003814] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2024] [Accepted: 12/17/2024] [Indexed: 01/23/2025]
Abstract
PURPOSE The study aims to compare dry eye disease (DED) prevalence and severity between seropositive and seronegative Sjögren disease (SjD). METHODS Prospective, consecutive, comparative cross-sectional cohort study. A total of 160 eyes of 80 patients with SjD by The American College of Rheumatology and the European League Against Rheumatism 2016 criteria were included: 55 seropositive and 25 seronegative SjD. Associated SjD was excluded. Patients had dry eye tests performed. Generalized estimating equations were used to account for intereye correlation of the same participant. RESULTS Mean age was 52.2 ± 12.7, 96.3% were women, no differences were observed between groups (P > 0.05). Seronegative SjD had positive minor salivary gland biopsy more often (100% vs. 82%, P = 0.024), but with lower focus score (2.0 ± 1.2 vs. 4.1 ± 3.5, P = 0.006) than seropositive SjD group. DED prevalence was similar in seropositive and seronegative SjD (92.7% and 84%; P = 0.088). Only noninvasive break-up time (NIBUT) average was significantly reduced in seropositive SjD (6.6 ± 3.2 vs. 8.8 ± 2.4, P = 0.011), and the rest of the evaluated DED tests were not significant. In the seropositive group, nonstatistically significant trends toward more severe DED signs, including matrix metalloproteinase-9, osmolarity, Schirmer I without anesthesia, fluorescein tear break-up time, NIBUT first, and Sicca Ocular Staining Score, were observed. Both groups were highly symptomatic in ocular surface disease index score (43 ± 23 vs. 46 ± 30, P = 0.779) and had a reduction in quality of life in National Eye Institute visual health questionnaire-25 test (72 ± 21 vs. 70 ± 24, P = 0.650). CONCLUSIONS Patients with seropositive SjD showed significantly reduced NIBUT and a trend of more severe DED signs. Patients with seronegative and seropositive SjD were similarly highly symptomatic, experienced important reductions in vision-related quality of life, and had similar DED prevalence.
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Affiliation(s)
| | - Janett Riega-Torres
- Rheumatology, University Hospital and Faculty of Medicine, Autonomous University of Nuevo León (UANL), Monterrey, México
| | | | | | - Oscar Eduardo Álvarez-González
- Rheumatology, University Hospital and Faculty of Medicine, Autonomous University of Nuevo León (UANL), Monterrey, México
| | | | | | - Mario Alberto Garza-Elizondo
- Rheumatology, University Hospital and Faculty of Medicine, Autonomous University of Nuevo León (UANL), Monterrey, México
| | - Dionicio Ángel Galarza-Delgado
- Rheumatology, University Hospital and Faculty of Medicine, Autonomous University of Nuevo León (UANL), Monterrey, México
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Lazreg S, Assaf AH, Abdelrahman AM, Hosny M, Shaheen MS, Shawky MM, El-Raggal TM, Abou Samra WAM, Mostafa YSE. Efficacy and safety of preservative-free anti-glaucomatous eye drops (dorzolamide/timolol) in ocular hypertension and/or glaucoma. Int Ophthalmol 2025; 45:30. [PMID: 39832060 DOI: 10.1007/s10792-025-03411-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Accepted: 01/06/2025] [Indexed: 01/22/2025]
Abstract
PURPOSE This study evaluated the efficacy, safety, and tolerability of a single-dose, preservative-free (PF) Dorzolamide/Timolol combination (Twinzol-SDU). METHODS A 3-month single-arm, multicenter, prospective cohort study was conducted in Egypt between January 2021 and October 2022 on previously diagnosed and controlled patients with ocular hypertension and/or glaucoma. Efficacy was assessed using the change in intraocular pressure (IOP) after 6 and 12 weeks. Safety was identified through the change in the incidence of ocular side effects, ocular surface disease index (OSDI) scores and grades, and Time Break-Up time (TBUT). RESULTS A total of 382 patients were enrolled in the analysis. After the three-month period of therapy, a significant reduction in IOP was seen (mean change: -1.9, P < 0.001) after switching to PF Dorzolamide/Timolol combination. The rate of ocular abrasion decreased significantly from 30.6% to 1.3% (P < 0.001). The rate of normal aqueous tear production increased from 24.1% to reach 79.4% (P < 0.001). The OSDI scores decreased significantly throughout the study period, with a median score decreased from 41.7 (21.7) to 12.5 (12.5) (P < 0.001). Mild OSDI grades significantly increased from the baseline of 12.6% to reach 24.7%. Moderate OSDI grade decreased at the same rate, from 12.8% to 11.1%. The number of patients with severe OSDI grade substantially decreased from 64.4% to 4.5%, with a P < 0.001. TBUT increased from 9 (3.7) seconds to reach and 12.3 (4) seconds after 12 weeks of treatment (P < 0.001). CONCLUSION Generally, the PF dorzolamide/timolol combination was associated with a significant reduction in IOP and tolerability among glaucoma patients.
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Affiliation(s)
- Sihem Lazreg
- Cornea and Ocular Surface Center Lazreg, 09000, Blida, Algeria.
| | - Ahmed Hassan Assaf
- Professor of Opthalmology, Ain Shams University, Consultant at Watany Eye Hospital, Cairo, Egypt
| | | | - Mohamed Hosny
- Professor of Ophthalmology, Cairo University, Cairo, Egypt
| | | | | | | | | | - Yehia Salah Eldin Mostafa
- Chairman and Professor of Ophthalmology, Kasr Alainy Faculty of Medicine, Cairo University, Giza, Egypt
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Sabucedo-Villamarin B, Garcia-Queiruga J, Pena-Verdeal H, Garcia-Resua C, Yebra-Pimentel E, Giraldez MJ. Diagnostic Cut-Off Values Based on Lipid Layer Pattern for Dry Eye Disease Subtypes Assessment. J Clin Med 2025; 14:623. [PMID: 39860629 PMCID: PMC11765754 DOI: 10.3390/jcm14020623] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Revised: 12/12/2024] [Accepted: 01/17/2025] [Indexed: 01/27/2025] Open
Abstract
Background: The aim of the present study was to establish a cut-off value of the Lipid Layer Pattern (LLP) between participants with different subtypes of Dry Eye Disease (DED) including Deficient Dry Eye (ADDE), Evaporative Dry Eye (EDE), and Mixed Dry Eye (MDE). Methods: 240 participants diagnosed with DED according to the Tear Film and Ocular Surface Society in the Dry Eye Workshop II guidelines were included in the study. Tear Meniscus Height (TMH) using the Tearscope illumination and Meibomian Gland Loss Area (MGLA) using the Keratograph 5M were assessed to categorize the participants into an ADDE group, EDE group, or MDE group. Then, the LLP was assessed using the Tearscope following the Guillon (LLP-G) and Colour (LLP-C) schemes. Results: Receiver Operating Characteristics (ROC) showed that both LLP-G and LLP-C have no diagnostic potential in distinguishing between ADDE and EDE participants (both p ≥ 0.724). However, to differentiate the ADDE participants from the MDE, ROC procedures showed a good diagnostic potential with cut-off values of Closed Meshwork-Wave (AUC ± SD = 0.609 ± 0.049, p = 0.038, sensitivity: 23.9%; specificity: 76.1%) and Grey-White (AUC ± SD = 0.611 ± 0.050, p = 0.034, sensitivity: 40.7%; specificity: 73.9%) for LLP-G and LLP-C, respectively. Also, a significant potential to distinguish between the EDE from MDE participants was found, with cut-off values of Closed Meshwork (AUC ± SD = 0.604 ± 0.049, p = 0.043, sensitivity: 40.8%; specificity: 76.1%) and Grey-White (AUC ± SD = 0.604 ± 0.051, p = 0.038, sensitivity: 44.7%; specificity: 73.9%) for LLP-G and LLP-C, respectively. Conclusions: Using the Tearscope, both LLP-G and LLP-C has diagnostic potential to distinguish MDE participants from the other subtypes of DED.
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Affiliation(s)
- Belen Sabucedo-Villamarin
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
| | - Jacobo Garcia-Queiruga
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
- Instituto de Investigación Sanitaria (IDIS), Travesía da Choupana S/N, 15701 Santiago de Compostela, Spain
| | - Hugo Pena-Verdeal
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
- Instituto de Investigación Sanitaria (IDIS), Travesía da Choupana S/N, 15701 Santiago de Compostela, Spain
| | - Carlos Garcia-Resua
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
- Instituto de Investigación Sanitaria (IDIS), Travesía da Choupana S/N, 15701 Santiago de Compostela, Spain
| | - Eva Yebra-Pimentel
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
- Instituto de Investigación Sanitaria (IDIS), Travesía da Choupana S/N, 15701 Santiago de Compostela, Spain
| | - Maria J. Giraldez
- GI-2092-Optometry, Departamento de Física Aplicada (Área de Optometría), Universidade de Santiago de Compostela, Campus Vida s/n, 15701 Santiago de Compostela, Spain; (J.G.-Q.); (C.G.-R.); (E.Y.-P.); (M.J.G.)
- Instituto de Investigación Sanitaria (IDIS), Travesía da Choupana S/N, 15701 Santiago de Compostela, Spain
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Landsend ECS, Istre M, Utheim TP. Lifitegrast in Treatment of Dry Eye Disease-A Practical, Narrative Expert Review. J Ophthalmol 2025; 2025:6504111. [PMID: 39850608 PMCID: PMC11756945 DOI: 10.1155/joph/6504111] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2023] [Revised: 11/13/2024] [Accepted: 12/31/2024] [Indexed: 01/25/2025] Open
Abstract
Purpose: Dry eye disease (DED) is a multifactorial disorder affecting millions worldwide. Inflammation plays a central role in DED. The aim of this review is to critically evaluate the literature concerning the efficacy and safety of lifitegrast, a small molecule immunomodulator that blocks the action of lymphocyte function-associated antigen-1. Methods: Studies were identified using PubMed and ClinicalTrials.gov. Fourteen studies met the inclusion criteria, six of which were randomized controlled trials. The articles were assessed regarding the effect of lifitegrast on symptoms and signs of DED, its usefulness compared to other treatments, and potential adverse events. Results: The analysis demonstrated positive effects of lifitegrast on subjective and objective parameters of DED in the selected studies. However, despite promising results, the included studies did not provide enough evidence to conclude that lifitegrast could outperform other treatments of DED. No major side effects were reported. Conclusions: Based on the current literature, we conclude that lifitegrast could improve various parameters of DED. Still, larger controlled trials are required to establish additional benefits of this medication beyond those of other DED treatments.
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Affiliation(s)
- Erlend C. S. Landsend
- Department of Ophthalmology, Oslo University Hospital, P.O. Box 4950, Nydalen, Oslo 0424, Norway
| | - Mads Istre
- Department of Ear, Nose and Throat, Akershus University Hospital, P.O. Box 1000, Lørenskog 1478, Norway
| | - Tor P. Utheim
- Department of Ophthalmology, Oslo University Hospital, P.O. Box 4950, Nydalen, Oslo 0424, Norway
- Department of Medical Biochemistry, Oslo University Hospital, P.O. Box 4950, Nydalen, Oslo 0424, Norway
- Department of Ophthalmology, Vestre Viken Hospital Trust, P.O. Box 800, Drammen 3004, Norway
- Department of Ophthalmology, Vestfold Hospital Trust, P.O. Box 2168, Tønsberg 3103, Norway
- Department of Ophthalmology, Sørlandet Hospital Trust, P.O. Box 416, Kristiansand 4604, Norway
- The Norwegian Dry Eye Clinic, Ole Vigs Gate 32E, Oslo 0366, Norway
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de Alcântara RJA, Wakamatsu TH, Hirai FE, Demeda VF, Frizon L, Pereira Gomes JÁ. Intense Pulsed Light in the Treatment of Dry Eye and Meibomian Gland Dysfunction in Patients With Chronic Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Cornea 2025:00003226-990000000-00782. [PMID: 39808205 DOI: 10.1097/ico.0000000000003800] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2024] [Accepted: 12/04/2024] [Indexed: 01/16/2025]
Abstract
PURPOSE To evaluate the efficacy and safety of intense pulsed light (IPL) combined with meibomian gland expression (MGX) for the treatment of dry eye disease and meibomian gland dysfunction associated with chronic Stevens-Johnson syndrome and toxic epidermal necrolysis. METHODS This prospective noncomparative interventional study included 29 patients (58 eyes) who underwent 3 sessions of IPL and MGX at 2-week intervals. Subjective symptoms (ocular surface disease index score) and objective dry eye tests: matrix metalloproteinase 9, tear meniscus height, bulbar redness score, tear film lipid layer thickness (LLT), Schirmer I test, conjunctival and corneal staining, meibomian gland loss, MGX score [meibomian gland score (MGS)], and tear break-up time were assessed at the baseline and after 4, 8, and 12 weeks. RESULTS Twenty-nine individuals (57 eyes) were included in this analysis. The ocular surface disease index score decreased significantly from 60.07 ± 23.34 (baseline) to 38.36 ± 22.39 (after 90 days) (P < 0.01). The fluorescein and lissamine green staining scores, MGS, and LLT improved significantly (P < 0.01). In contrast, there were no significant changes in the tear meniscus height values, matrix metalloproteinase 9 positivity, bulbar redness score, Schirmer test, meibography of the superior and inferior eyelids, and tear break-up time. Ocular or skin complications were not observed. CONCLUSIONS Three IPL therapy sessions followed by MGX seemed to be safe and effective in treating dry eye disease and meibomian gland dysfunction, improving vision-related quality of life, dry eye symptoms, and ocular surface signs, such as corneal and conjunctival staining scores, MGS, and LLT after 90 days in patients with chronic Stevens-Johnson syndrome and toxic epidermal necrolysis.
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Affiliation(s)
- Rafael Jorge Alves de Alcântara
- Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil
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Bachtalia K, Plakitsi A, Voudouri A, Terzidou C, Dalianis G, Kopsinis G, Palioura S. The Effect of Autologous Serum Tears 50% on the Ocular Surface of Patients With Severe Dry Eye Disease due to Sjogren Syndrome: A Prospective, Double-Blind, Randomized, Controlled, Contralateral Eye Study. Cornea 2025:00003226-990000000-00788. [PMID: 39808128 DOI: 10.1097/ico.0000000000003795] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2024] [Accepted: 11/26/2024] [Indexed: 01/16/2025]
Abstract
PURPOSE To assess the impact of autologous serum (AS) tears at a 50% concentration on the ocular surface of patients with refractory dry eye disease (DED) because of Sjogren syndrome. METHODS Twenty eyes of ten patients with severe immune-mediated DED were contralaterally randomized to receive either AS tears 50% or artificial tears between June 2021 and May 2023. Changes in tear stability, ocular surface staining, and in the morphology of the corneal sub-basal nerves were evaluated before treatment and at 1, 2, and 3 months after treatment using objective tests for DED and confocal microscopy. The microbiological safety of the used AS tears 50% was investigated using Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry. RESULTS The AS tears 50% group exhibited significant improvements in tear break-up time, Schirmer test scores, visual acuity, and confocal microscopy parameters of corneal nerve health at the 3-month follow-up (P < 0.05). Corneal nerve regeneration correlated with increased tear stability and decreased ocular surface staining. Microbiological analysis identified Gram-negative bacteria in the postuse AS tears, highlighting the need for meticulous handling and storage practices. CONCLUSIONS Treatment with AS tears at a 50% concentration markedly enhances ocular surface health, tear stability, and visual acuity, affirming the regenerative effects on corneal nerves in severe DED. The findings advocate for the therapeutic potential of higher-concentration AS tears in DED management, albeit with strict protocols to mitigate contamination risks and ensure patient safety.
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Affiliation(s)
- Konstantina Bachtalia
- Department of Biomedical Sciences, University of West Attica (UNIWA), Athens, Greece
| | - Athina Plakitsi
- Department of Biomedical Sciences, University of West Attica (UNIWA), Athens, Greece
| | | | - Chryssa Terzidou
- Konstantopouleio General Hospital of Nea Ionia "'Agia Olga", Athens, Greece
| | - Georgios Dalianis
- Konstantopouleio General Hospital of Nea Ionia "'Agia Olga", Athens, Greece
| | | | - Sotiria Palioura
- Department of Ophthalmology, University of Cyprus Medical School, Nicosia, Cyprus
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Ta H, McCann P, Xiao M, Lien T, Abbott K, Gregory DG, Qureshi R, Li T. Dry eye post-cataract surgery: a systematic review and meta-analysis. BMC Ophthalmol 2025; 25:18. [PMID: 39806338 PMCID: PMC11726945 DOI: 10.1186/s12886-024-03841-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2024] [Accepted: 12/31/2024] [Indexed: 01/16/2025] Open
Abstract
SIGNIFICANCE Cataract surgery is one of the most performed surgical procedures worldwide. As a potential complication following cataract surgery, dry eye has the potential to impact visual outcomes, lower patient satisfaction, and be detrimental to quality of life. PURPOSE To evaluate the effect of cataract surgery on dry eye outcomes postoperatively. METHODS We searched Ovid MEDLINE and Embase from 01/01/2010 to 16/08/2021 and included observational studies of participants ≥ 18 years old undergoing any cataract surgical procedure. We compared postoperative dry eye outcomes with baseline including Ocular Surface Disease Index (OSDI), tear break up time (TBUT), Schirmer's I test (ST1), and corneal fluorescein staining (CFS) at short-term (< 1 week) and medium-term (≥ 1 week to 3 months) follow-up. RESULTS Our search yielded 11,133 records. After title and abstract, and then full text screening, we included 20 studies with 1,694 eyes. There was some evidence indicating a decrease in the TBUT during the short-term (within 1 week) and medium-term (1 week up to 3 months) periods following cataract surgery. There was a considerable degree of heterogeneity between studies across other outcomes. At medium-term follow-up most studies that reported ST1 and CFS showed deterioration of these outcomes but there was conflicting evidence of the effect of cataract surgery on OSDI. The review is limited by variability in follow-up timeframes which were unable capture potential clinical course like peak occurrence and duration. CONCLUSION Dry eye may persist up to three months postoperatively following cataract surgery. Further studies are required to determine if dry eye outcomes return to baseline at longer term follow-up.
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Affiliation(s)
- Hillary Ta
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Paul McCann
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Mengli Xiao
- Department of Biostatistics & Informatics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Tiffany Lien
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Kaleb Abbott
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Darren G Gregory
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Riaz Qureshi
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
- Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA
| | - Tianjing Li
- Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
- Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA.
- Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, 1675 Aurora Ct., F731, Aurora, CO, 80045, USA.
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Gao J, Lai Z, Hu Y, Yang X. Translation and validation of the 8-item contact lens dry eye questionnaire (CLDEQ-8) among Chinese soft contact lens wearers. Cont Lens Anterior Eye 2025:102366. [PMID: 39799006 DOI: 10.1016/j.clae.2024.102366] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2024] [Revised: 12/31/2024] [Accepted: 12/31/2024] [Indexed: 01/15/2025]
Abstract
PURPOSE To develop a Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) with cross-cultural adaption and clinical validation among soft contact lens wearers (SCL) in China. METHODS The translation and adaptation of the Chinese CLDEQ-8 (C-CLDEQ-8) followed a rigorous methodological process based on cross-cultural research guidelines consisting of three main phases: 1) forward and backward translation of original CLDEQ-8 into Chinese, 2) cross-cultural adaptation performed by medical advising committee, and 3) clinical validation and repeatability test of the translated questionnaire on Chinese SCL wearers. Rasch analysis was also performed to investigate the psychometric properties of C-CLDEQ-8. RESULTS 134 experienced SCL wearers aged 18-45 completed the C-CLDEQ-8. C-CLDEQ-8 score was linearly related to the overall opinion of SCLs (beta = 2.16, p = 0.002), gestalt eye dryness response (beta = 2.90, p < 0.001), and sensitivity response (beta = 1.83, p = 0.001). The questionnaire showed excellent test-retest repeatability with an intra-class correlation coefficient (ICC) of 0.95 and great internal consistency with a Cronbach's alpha of 0.83. The corrected index of homogeneity for each item was more significant than 0.5. In Rasch analysis, the infit and outfit values for eight items were all within 0.6-1.4, suggesting a good fit for the Rasch model. Martin-Löf test result indicated that the Rasch model was unidimensional (p = 1.0). Item characteristics curves suggested combining categories 3-4 and 5-6 in item 5 of C-CLDEQ-8. CONCLUSIONS This study produced a Chinese version of CLDEQ-8 with great validity and reliability and proved capable of evaluating SCL-related symptoms.
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Affiliation(s)
- Jiajia Gao
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China
| | - Zhipeng Lai
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China
| | - Yin Hu
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China
| | - Xiao Yang
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.
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Gutiérrez P, Jiménez L, Martínez J, Alba C, Girón MV, Olveira G, Ruiz-Esteban P, Olveira C. Dry eye disease and morphological changes in the anterior chamber in people with cystic fibrosis. J Cyst Fibros 2025:S1569-1993(24)01860-5. [PMID: 39779380 DOI: 10.1016/j.jcf.2024.12.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2024] [Revised: 12/20/2024] [Accepted: 12/20/2024] [Indexed: 01/11/2025]
Abstract
BACKGROUND Cystic fibrosis (CF) is caused by variants in a gene that encodes a protein essential for water and ion transport in the epithelial cells of exocrine organs. Given the possible relationship of this protein and conjunctival and corneal epithelium, the aim of this study was to evaluate ophthalmologic alterations in people with CF. METHODS Forty-five people with CF underwent pulmonary evaluation including inflammatory score (IS). These people along with 98 sex-matched controls underwent ophthalmologic evaluation including dry eye disease (DED) testing, corneal topography using Pentacam™ and macular and peripapillary retinal nerve fiber layer (pRNFL) thickness with optical coherence tomography (OCT). RESULTS The CF group presented a higher percentage of pathologic tear break-up time (T-BUT) (55.6 % vs 25 %, p = 0.001) and Schirmer's test 1 (40 % versus 19.4 %, p = 0.009) than the control group. In the CF group, an inverse correlation was observed between T-BUT and IS (r=- 0.373, p = 0.012), as well as T-BUT and peripheral eosinophilia (r=-0.338; p = 0.023). People with CF presented lower values of central corneal thickness (p = 0.009), thinnest point (p = 0.006), anterior chamber volume (p = 0.034), and anterior chamber angle (p = 0.011) than the control group and lower pRNLF thickness in the superior temporal sector (p = 0.002). CONCLUSIONS Our findings indicate a higher prevalence of dry eye disease (DED) among people with CF compared to controls. The severity of the condition increases with higher systemic inflammation. Additionally, CF may affect the anterior segment of the eye, leading to a reduction in the nerve fiber layer and early signs of glaucoma.
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Affiliation(s)
- Patricia Gutiérrez
- Ophthalmology Department, Regional University Hospital of Malaga, University of Malaga, Spain
| | - Laura Jiménez
- Ophthalmology Department, Regional University Hospital of Malaga, University of Malaga, Spain
| | - Jessica Martínez
- Pulmonology Department, Regional University Hospital of Malaga, University of Malaga, Spain
| | - Carmen Alba
- Ophthalmology Department, Virgen de la Victoria University Hospital, University of Malaga, Biomedical Research Institute of Malaga (IBIMA) - Bionand Platform, Spain
| | - María Victoria Girón
- Pulmonology Department, Regional University Hospital of Malaga, University of Malaga, Spain
| | - Gabriel Olveira
- Endocrinology Department, Regional University Hospital of Malaga, Department of Medicine and Dermatology, University of Malaga, Biomedical Research Institute of Malaga (IBIMA) - Bionand Platform, Spain
| | - Pedro Ruiz-Esteban
- Nephrology Department, Regional University Hospital of Malaga, University of Malaga, Institute of Biomedical Research in Malaga (IBIMA) - Bionand Platform, RICORS2040 (RD21/0005/0012), E-29010, Malaga, Spain.
| | - Casilda Olveira
- Pulmonology Department, Regional University Hospital of Malaga, Department of Medicine and Dermatology, University of Malaga, Biomedical Research Institute of Malaga (IBIMA) - Bionand Platform, Malaga, Spain.
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Zhang F, Tan M, Hu ZE, Zhang YT, Qi XW, Che YT, Li J, Zhang S, Li BJ. A hyaluronic acid-modified cyclodextrin self-assembly system for the delivery of β-carotene in the treatment of dry eye disease. Int J Biol Macromol 2025; 287:138428. [PMID: 39647723 DOI: 10.1016/j.ijbiomac.2024.138428] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Revised: 11/24/2024] [Accepted: 12/03/2024] [Indexed: 12/10/2024]
Abstract
Dry eye disease (DED) is a multifactorial ocular disease, the core mechanism of which is the tear film instability caused by ocular oxidative stress damage and inflammation. Although various pharmaceutical agents are available for DED treatment, their effectiveness is often limited by the eyes' unique biological barriers, and the long-term use of steroid hormones can lead to several adverse effects. This study reported a nano-supramolecular delivery system consisting of a polycyclodextrin (PCD), hyaluronic acid (HA) and the natural compound β-carotene (BC) for the DED treatment. Our findings indicate that the HA/PCD@BC eye drops effectively distribute on the ocular surface, retain BC, and significantly enhance the corneal penetration of BC. The excellent biocompatibility of HA/PCD@BC was demonstrated through viability testing on different cell lines, the Draize eye test, as well as the hematoxylin-eosin staining (H&E) sections of cornea and conjunctiva. Both in vitro oxidative stress assays and in vivo DED model evaluations demonstrated that the HA/PCD@BC delivery system significantly reduced abnormal oxidative stress levels on the ocular surface, inhibited the secretion of inflammatory factors, and increased the secretion of tear film stabilizing mucin. These effects collectively improved pathological changes in eye tissues and minimized damage to the ocular surface. It is of particular importance to note that HA/PCD@BC eye drops showed superior efficacy in comparison to cyclosporine A (CsA), an FDA-approved first-line drug. To sum up, the HA/PCD@BC nanodelivery system provides a natural, safe and effective therapeutic strategy for the treatment of DED and various ocular diseases.
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Affiliation(s)
- Fuzhong Zhang
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Min Tan
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Zu-E Hu
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Ye-Tao Zhang
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Xu-Wei Qi
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Yu-Ting Che
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China
| | - Jing Li
- State Key Laboratory of Polymer Materials Engineering, Polymer Research Institute of Sichuan University, Sichuan University, Chengdu 610065, China
| | - Sheng Zhang
- State Key Laboratory of Polymer Materials Engineering, Polymer Research Institute of Sichuan University, Sichuan University, Chengdu 610065, China.
| | - Bang-Jing Li
- Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China; University of Chinese Academy of Sciences, Beijing 100049, China.
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Sawaed A, Friedrich SN, Farhan A, Nassar A, Hamed M, Hartstein M, Hamed Azzam S. The effect of botulinum neurotoxin A injections on meibomian glands and dry eye. Ocul Surf 2025; 35:25-30. [PMID: 39622451 DOI: 10.1016/j.jtos.2024.11.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Revised: 09/24/2024] [Accepted: 11/29/2024] [Indexed: 12/07/2024]
Abstract
PURPOSE To assess the influence of Botulinum neurotoxin A (BoNT-A) injection on meibomian gland function and dry eye in patients diagnosed with Blepharospasm (BPS) and Hemifacial spam (HFS). METHODS Adult patients aged 18 years or older who suffer from periocular dystonia, and were treated with BoNT-A injections, were recruited in this interventional prospective study between 2023 and 2024. Each patient was followed up for a period of three months. The following parameters were compared at baseline, 14 and 90 days post BoNT-A injections: Visual acuity, meibography, tear break up time (TBUT), Schirmer test, meibum expression, tear meniscus height, fluorescein corneal staining, meibomian gland dysfunction (MGD) grading, and ocular surface disease index (OSDI). In addition, patients underwent subjective quality of life questionnaire for BPS and HFS. RESULTS Thirty-six eyes of twenty-six patients were included in this study. The mean age ±SD was 59 ± 17.33 years. There was a significant statistical difference in vascular changes on the lid margin, TBUT, corneal and conjunctival fluorescein staining and meibum expression (P < 0.001 in all). The differences were statistically significant when compared to baseline vs visit 2, and visit 2 vs visit 3 (p-value<0.05). Jankovic rating scale and HFS score improved significantly between the time periods (P < 0.001 in both). There was no significant difference in meibomian gland loss, tear meniscus height, Schirmer test, and OSDI. CONCLUSION BoNT-A injection is an effective treatment for periocular dystonia, but it worsens ocular surface and dry eye disease. Moreover, it affects the meibomian glands by disturbing their secretion.
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Affiliation(s)
- Ali Sawaed
- Ophthalmology department, Tzafon Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, Israel
| | | | - Abed Farhan
- Ophthalmology department, Tzafon Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, Israel
| | - Aseel Nassar
- Ophthalmology department, Tzafon Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, Israel
| | - Mira Hamed
- Dermatology department, Emek Medical Center, Afula, Israel
| | - Morris Hartstein
- Department of Ophthalmology, Shamir Medical Center, Tzrifin, Israel
| | - Shirin Hamed Azzam
- Ophthalmology department, Tzafon Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, Israel.
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Downie LE, Craig JP, Stapleton F, Tan J, Jones LW, Ng A, Hinds M, Bosworth C, Alster Y. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial. Ocul Surf 2025; 35:15-24. [PMID: 39613259 DOI: 10.1016/j.jtos.2024.11.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2024] [Revised: 11/06/2024] [Accepted: 11/26/2024] [Indexed: 12/01/2024]
Abstract
PURPOSE To determine the efficacy and safety of AZR-MD-001 (0.5 % and 1.0 %) ophthalmic ointment, relative to vehicle, over 3-6 months of treatment, in participants with meibomian gland dysfunction (MGD). METHODS This was a Phase 2, randomized, vehicle-controlled, multicenter extension clinical trial. Eligible participants were adults with MGD (meibomian gland secretion score (MGS) ≤12 out of 15 glands) who discontinued all other dry eye or MGD treatments. Participants were randomized 1:1:1 to apply AZR-MD-001 1.0 %, 0.5 %, or vehicle to the lower eyelids, twice weekly. Key exploratory endpoints included the least-squared mean difference between groups in the change from baseline in clinical signs (meibomian gland yielding score; MGYLS) and symptoms (Ocular Surface Disease Index; OSDI), at clinic visits at Month 4.5 and 6, and safety measures from 36 months. RESULTS Participants (66.5 % female) were randomized, at baseline, to AZR-MD-001 0.5 % (n = 82), 1.0 % (n = 83), or vehicle (n = 80). Statistically significant improvements, compared to vehicle, were observed at Month 6 in MGYLS for both AZR-MD-001 groups (0.5 % group: 1.9, 95 % CI 0.9 to 2.8, P = 0.002; 1.0 % group: 1.1, 95 % CI 0.2 to 2.1, P = 0.026), and in OSDI score for the 0.5 % group (-4.5, 95 % CI -8.0 to -0.9, P = 0.0135). The most common adverse events for AZR-MD-001 were application site pain, superficial punctate keratitis and eye pain; most were mild to moderate in severity, and decreased in incidence over time. CONCLUSIONS AZR-MD-001 (0.5 %) was efficacious in treating signs and symptoms of MGD over six months, with a lower observed incidence of new adverse events over time.
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Affiliation(s)
- Laura E Downie
- Department of Optometry and Vision Sciences, University of Melbourne, Parkville, Victoria, Australia
| | - Jennifer P Craig
- Department of Ophthalmology, Aotearoa New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand
| | - Fiona Stapleton
- School of Optometry and Vision Science, UNSW Sydney, Sydney, Australia
| | - Jacqueline Tan
- School of Optometry and Vision Science, UNSW Sydney, Sydney, Australia
| | - Lyndon W Jones
- Centre for Ocular Research and Education (CORE), University of Waterloo, Waterloo, Canada
| | - Alison Ng
- Centre for Ocular Research and Education (CORE), University of Waterloo, Waterloo, Canada
| | - Mark Hinds
- Ophthalmic Trials Australia, Brisbane, Australia
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Yvon C, Malhotra R. Outcomes of conjunctivochalasis treatment after fornix deepening with retractor recession and repositioning. Eur J Ophthalmol 2025; 35:383-391. [PMID: 39300793 DOI: 10.1177/11206721241283063] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/22/2024]
Abstract
PURPOSE To evaluate outcomes of fornix deepening with retractor recession and repositioning for conjunctivochalasis (CCh) on improvement of conjunctival folds and ocular surface symptoms, particularly epiphora. METHODS Retrospective, single-centre, observational case series of patients with refractory CCh who underwent fornix deepening and retractor recession. CCh was graded using the Hoh classification (grades 0 to 3 depending on the number and height of folds). Epiphora, reflex tearing, and dry eye symptoms were assessed using the validated 'TEAR' score pre- and post-CCh correction. RESULTS 18 eyes of 11 patients with CCh (average age 68, range 46-82 years) were treated with fornix deepening and retractor recession. All had shallow fornices pre-operatively with a mean CCh grade of 1.7 (typically lower than the tear meniscus). Locations of the folds were variable: diffuse/middle (n = 10), nasal (n = 4), and temporal (n = 4). At 15-month mean follow-up, conjunctival redundancy was absent in 17 of 18 eyes postoperatively, resulting in a restored tear meniscus and reservoir. 91% saw a reduction in tearing frequency (T), with 73% gaining ≥ 2-point improvement. Improvements in clinical effects (E) and activity limitation (A) were seen in 82% and 91% of patients, respectively, with 36% and 64% gaining ≥ 2-point improvement. R scores (related to reflex tearing) improved in 73%, with 64% seeing ≥ 2-point gains. (P < 0.05 for all). CONCLUSION Restoration of the tear reservoir by inferior fornix deepening with retractor recession and repositioning can result in improvement of CCh and epiphora.
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Affiliation(s)
- Camille Yvon
- Corneoplastic unit, Queen Victoria Hospital NHS Trust, East Grinstead, Sussex, UK
| | - Raman Malhotra
- Corneoplastic unit, Queen Victoria Hospital NHS Trust, East Grinstead, Sussex, UK
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Ngo W, Nagaarudkumaran N, Huynh CB. Refrigeration reduces instillation discomfort of a 0.09% cyclosporine A solution. Optom Vis Sci 2025; 102:14-19. [PMID: 39704709 DOI: 10.1097/opx.0000000000002205] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2024] Open
Abstract
SIGNIFICANCE Topical cyclosporine A (CsA) for the treatment of dry eye disease is often associated with instillation discomfort, which may negatively influence patient adherence to therapy. This study found that refrigerating topical CsA reduced instillation discomfort compared with instillation of warm CsA. Thus, refrigerating CsA prior to instillation may improve patient experience when using CsA to manage dry eye disease. PURPOSE This study aimed to quantify instillation discomfort associated with cold or warm instillation of a 0.09% CsA. METHODS Forty participants with symptomatic aqueous deficient dry eye were enrolled. A drop of cold (4°C) CsA was instilled in one eye, and a drop of warm (23°C) CsA was instilled in the other eye. The order and eye receiving the cold drop were randomized. Participants rated the discomfort of each eye (0, no discomfort; 10, maximal discomfort) prior to drop instillation, immediately post-instillation, and at each subsequent minute for 10 minutes. Area under the curve was used to quantify cumulative discomfort. RESULTS Forty participants (39.6 ± 18.9 years old, 82% female) completed the study. A majority of participants (n = 24, 60%) experienced reduced cumulative discomfort with cold CsA, whereas the remainder experienced minimal difference (n = 10, 25%) or increased cumulative discomfort (n = 6, 15%). For those with reduced discomfort (n = 24), cumulative discomfort associated with cold instillation (median, 11.5 [2.2, 20.0]) was significantly lower (p<0.01) than cumulative discomfort associated with warm instillation (median, 17.5 [11.2, 32.2]). Cold instillation was associated with a median reduction of 1 discomfort point immediately post-instillation and at all subsequent time points (all p≤0.04, but not significant at t = 10), compared with warm instillation. CONCLUSIONS Up to 60% of participants found that cold instillation of CsA solution induced less discomfort than warm instillation, lasting up to 9 minutes post-instillation. In contrast, although 15% of participants found reduced discomfort with warm instillation, the magnitude of discomfort associated with warm instillation was not significantly different than cold instillation.
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Affiliation(s)
| | - Nijani Nagaarudkumaran
- Centre for Ocular Research and Education, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada
| | - Cassandra Bonnie Huynh
- School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada
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