NCT07142785

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Epiretinal membrane peeling	All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: China