With versus without internal limiting membrane peeling during surgery for idiopathic epiretinal membrane
Official title: Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07142785 · Data updated 2026-11-12
This trial will try removing the internal limiting membrane during vitrectomy to see if it improves vision or symptoms for adults with idiopathic epiretinal membrane who have reduced visual acuity or metamorphopsia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | August 27, 2025 |
| Trial ID | NCT07142785 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with idiopathic epiretinal membrane who have best-corrected visual acuity ≤ 0.6 or symptomatic metamorphopsia, without other macular disease and eligible for vitrectomy, are ideal candidates.
✕Probably not a fit
Patients with secondary ERM, concomitant macular pathology, prior ocular surgery (except cataract), severe systemic disease, poor compliance, or psychiatric disorders are excluded and unlikely to benefit from this trial's interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares vitrectomy with epiretinal membrane peeling alone versus vitrectomy with both epiretinal membrane and internal limiting membrane (ILM) peeling in adults with idiopathic ERM. Eligible patients are randomized to one of the two surgical approaches and followed prospectively to measure visual outcomes, symptom changes, anatomical results, and safety events. Primary outcomes include best-corrected visual acuity and metamorphopsia, with secondary outcomes including macular anatomy and recurrence rates. The study is conducted at a single tertiary eye center using standardized surgical and follow-up protocols.
Why it matters
Potential benefit: If successful, the trial could clarify whether adding or omitting ILM peeling leads to better visual recovery, fewer recurrences, or fewer complications, guiding surgeons to the safer, more effective approach.
How similar studies have gone: Previous observational studies and smaller trials have shown mixed results—some report lower recurrence with ILM peeling but no consistent visual advantage—so high-quality randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Yueyang Zhong, MD.
- Email: yyzbzhong@zju.edu.cn
- Phone: +8618868125901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.