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
Abstract
BACKGROUND

Autologous serum eye drops (ASEDs), a novel treatment derived from blood serum, have emerged as a groundbreaking solution for managing dry eye syndrome (DES). These drops have shown significant promise in relieving the distressing symptoms of DES. This study aimed to evaluate the safety and effectiveness of ASEDs compared to traditional treatments, which often prove inadequate or result in unwanted side effects, particularly in individuals with moderate-to-severe DES.

AIM

To evaluate whether ASEDs are safer and more effective than conventional artificial tears in the treatment of moderate-to-severe DES.

METHODS

This multi-centered randomized controlled trial included 240 patients with moderate-to-severe DES from three ophthalmology clinics in China. They were randomly assigned to receive either ASEDs or artificial tears for 12 wk. 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). Statistics analysis was performed using an analysis of covariance with adjustments made for baseline values.

RESULTS

Our findings revealed that both ASEDs and artificial tears significantly improved the OSDI score, TBUT, Schirmer I test, CFS, and CIC from baseline to week 12. The ASEDs group showed significantly greater improvement in all these measures than the artificial tears group (all P values < 0.05). The average difference in the OSDI score between the two cohorts was -10.3 (95% confidence interval: -13.6 to -7.0), indicating a substantial improvement in the ASEDs group. The occurrence of adverse events was comparable between cohorts, with no reports of severe adverse events.

CONCLUSION

ASEDs are more effective and safer than artificial tears for mitigating symptoms of moderate-to-severe DES. ASEDs could be an alternative/supplementary therapy for patients with DES less responsive to traditional treatments.

Keywords: Autologous serum eye drops; Dry eye syndrome; Safety; Effectiveness; Alternative therapy; Conventional artificial tears

Core Tip: Autologous serum eye drops (ASEDs) are safe and effective alternative therapies for managing moderate-to-severe dry eye syndrome (DES). The study comparing ASEDs to conventional artificial tears found that ASEDs significantly improved the ocular surface disease index score, tear break-up time, Schirmer I test, corneal fluorescein staining, and conjunctival impression cytology over 12 wk. The ASEDs group showed greater improvement in these measures than the artificial tears group. Moreover, no severe adverse events were reported, indicating the safety of the ASEDs. These findings suggest that ASEDs are a valuable treatment option for patients with DES who respond poorly to traditional therapies.