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

Zhejiang University

Status: Enrolling

Conditions: Idiopathic Epiretinal Membranes

Treatments: Procedure: Epiretinal membrane peeling; Procedure: Epiretinal membrane peeling combined with internal limiting membrane peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT07142785

20250974

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Internal limiting membrane (ILM) peeling group

Experimental group

Description:

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.

Treatment:

Procedure: Epiretinal membrane peeling combined with internal limiting membrane peeling

No ILM peeling group

Active Comparator group

Description:

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

Treatment:

Procedure: Epiretinal membrane peeling