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

NCT07142785 | Recruiting DMC

• 1 other identifier: 20250974
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Epiretinal Membranes

Keywords

Idiopathic epiretinal membrane; internal limiting membrane; visual field; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean deviation (MD) value

  mean deviation (MD) value from postoperative Humphrey visual field testing.

  6 months postoperatively

Secondary Outcomes (3)

• Visual acuity

  6 months postoperatively

• Ganglion cell complex

  6 months postoperatively

• Recurrence rate

  12 months postoperatively

Study Arms (2)

Internal limiting membrane (ILM) peeling group

EXPERIMENTAL

The patients will receive standard pars plana vitrectomy with ERM peeling combined with ILM peeling within an area of 3-4 disc diameters centered on the macula.

Procedure: Epiretinal membrane peeling combined with internal limiting membrane peeling

No ILM peeling group

ACTIVE COMPARATOR

The patients will receive standard pars plana vitrectomy with only ERM peeling

Procedure: Epiretinal membrane peeling

Interventions

Epiretinal membrane peeling PROCEDURE

All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.

No ILM peeling group

Epiretinal membrane peeling combined with internal limiting membrane peeling PROCEDURE

All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling.

Internal limiting membrane (ILM) peeling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310058, China

RECRUITING

Central Study Contacts

Yueyang Zhong, MD.

CONTACT

+8618868125901; yyzbzhong@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be masked to the treatment group in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)