RecruitingNot Applicable

Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial

China96 participantsStarted 2025-09-01

Plain-language summary

Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged \>18 years presenting to our hospital within the study period. * Patients diagnosed with idiopathic epiretinal membrane (ERM) based on examination. * Patients with best-corrected visual acuity (BCVA) ≤ 0.6 or the presence of metamorphopsia. Exclusion Criteria: * Patients with secondary ERM identified during preoperative evaluation (e.g., secondary to retinal vein occlusion). * Patients with concomitant ocular diseases affecting the macula, such as macular degeneration, macular schisis, or macular atrophy. * Patients with a history of ocular trauma or previous ocular surgery (except for cataract surgery). * Patients with severe systemic diseases contraindicated for surgery. * Patients with poor compliance or concomitant psychiatric disorders. * Patients who participated in other clinical trials during the follow-up period or who were lost to follow-up.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean deviation (MD) value

Timeframe: 6 months postoperatively

Trial details

NCT IDNCT07142785

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Yueyang Zhong, MD.

+8618868125901 yyzbzhong@zju.edu.cn

View on ClinicalTrials.gov More Idiopathic Epiretinal Membranes trials