Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Oct 6, 2023; 11(28): 6774-6781
Published online Oct 6, 2023. doi: 10.12998/wjcc.v11.i28.6774
Randomized controlled trial on the efficacy and safety of autologous serum eye drops in dry eye syndrome
Na Zheng, Si-Quan Zhu
Na Zheng, Department of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu 610032, Sichuan Province, China
Si-Quan Zhu, Department of Ophthalmology, Beijing Anzhen Hospital Affiliated to China Medical University, Beijing 100029, China
Author contributions: Zheng N proposed the concept of this study, guided research, and drafted the first draft; Zhu SQ and Zheng N contributed to the data collection, survey, visualization of this study, and also validated this study, reviewed and edited the manuscript; Zhu SQ contributed to formal analysis and the methods.
Institutional review board statement: This study was reviewed and approved by the Medical Ethics Committee of the School of Ophthalmology, Chengdu University of Traditional Chinese Medicine.
Clinical trial registration statement: This study was registered at the Clinical Medical Center The registration identification number is Researchregistry8973.
Informed consent statement: This study has obtained informed consent from the patient or guardian.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Si-Quan Zhu, MD, Chief Doctor, Department of Ophthalmology, Beijing Anzhen Hospital Affiliated to China Medical University, No. 2 Anzhen Road, Chaoyang District, Beijing 100029, China. gveuhxsb@yeah.net
Received: August 8, 2023
Peer-review started: August 8, 2023
First decision: August 24, 2023
Revised: August 31, 2023
Accepted: September 14, 2023
Article in press: September 14, 2023
Published online: October 6, 2023
Processing time: 48 Days and 8.5 Hours
ARTICLE HIGHLIGHTS
Research background

Autologous serum eye drops (ASEDs) have emerged as a groundbreaking solution for managing dry eye syndrome (DES).

Research motivation

This study aimed to evaluate the safety and effectiveness of ASEDs compared to traditional treatments for moderate-to-severe DES.

Research objectives

The main objective of this study was to evaluate the safety and effectiveness of ASEDs compared to conventional artificial tears in the treatment of moderate-to-severe DES.

Research methods

A multi-centered randomized controlled trial (RCT) was conducted involving 240 patients from three ophthalmology clinics in China. The primary outcome was the change in the ocular surface disease index (OSDI) score, with secondary outcomes including tear break-up time (TBUT), Schirmer I test, corneal fluorescein staining (CFS), and conjunctival impression cytology (CIC).

Research results

Results showed that ASEDs were significantly more effective than artificial tears in improving these measures without severe adverse events. ASEDs are considered a valuable alternative therapy for DES patients unresponsive to traditional treatments.

Research conclusions

The study demonstrated that ASEDs are both more effective and safer than conventional artificial tears for the treatment of moderate-to-severe DES. The ASEDs group exhibited significant improvements in the OSDI score, TBUT, Schirmer I test, CFS, and CIC compared to the artificial tears group. The average difference in the OSDI score between the two groups was substantial, indicating a notable improvement in the ASEDs group. Importantly, no severe adverse events were reported in either group. These findings establish ASEDs as a valuable alternative or supplementary therapy for DES patients who do not respond well to traditional treatments.

Research perspectives

The research findings highlight the potential of ASEDs as a promising therapy for moderate-to-severe DES. Further studies could explore the long-term effects of ASEDs and compare their efficacy with other emerging treatments. Additionally, investigating the underlying mechanisms of action of ASEDs and identifying patient characteristics that predict treatment response would contribute to personalized treatment approaches. Cost-effectiveness analyses and evaluations in diverse populations would provide valuable insights into the broader applicability of ASEDs. Furthermore, exploring combination therapies incorporating ASEDs and evaluating their synergistic effects may yield enhanced outcomes for DES management. Continued research and clinical trials are warranted to advance the understanding and implementation of ASEDs in the field of ophthalmology.