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

NCT ID: NCT07142785

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-06-30

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.

Detailed Description

Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. Its pathological hallmark is the formation of a fibrocellular membrane in the macular region, which can lead to retinal structural distortion and visual impairment. Epidemiological studies indicate that ERM is age-related, occurs more frequently unilaterally, and shows a positive correlation with advancing age, with incidence rates of 2% to 20% in individuals aged 50 to 70 years. The severity primarily depends on the location and thickness of the membrane and the presence of macular pseudoholes, manifesting as symptoms including visual field distortion (metamorphopsia), micropsia, and central vision loss. Studies suggest that ERM patients experiencing progressive visual decline, best-corrected visual acuity (BCVA) ≤ 0.6, or severe metamorphopsia require surgical intervention. There remains a lack of high-quality prospective RCTs evaluating the therapeutic outcomes of vitrectomy combined with ERM peeling with or without ILM peeling in idiopathic ERM patients. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.

Conditions

Idiopathic Epiretinal Membranes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Internal limiting membrane (ILM) peeling group

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.

Group Type: EXPERIMENTAL

Epiretinal membrane peeling combined with internal limiting membrane peeling

Intervention Type: PROCEDURE

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

No ILM peeling group

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

Group Type: ACTIVE_COMPARATOR

Epiretinal membrane peeling

Intervention Type: PROCEDURE

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

Interventions

Epiretinal membrane peeling

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

Intervention Type: PROCEDURE

Epiretinal membrane peeling combined with internal limiting membrane peeling

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yueyang Zhong, MD.

Role: CONTACT

yyzbzhong@zju.edu.cn

+8618868125901

Facility Contacts

Yueyang Zhong

Role: primary

yyzbzhong@zju.edu.cn

18868125901

Other Identifiers

20250974

Identifier Type: -

Identifier Source: org_study_id