Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epiretinal membrane peeling, Epiretinal membrane peeling combined with internal limiting membrane peeling.
- Who it may be relevant to
- Registry conditions: Idiopathic Epiretinal Membranes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Mean deviation (MD) value [Time frame: 6 months postoperatively]
Secondary outcome measures (3)
- Visual acuity [Time frame: 6 months postoperatively]
- Ganglion cell complex [Time frame: 6 months postoperatively]
- Recurrence rate [Time frame: 12 months postoperatively]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Eye Center of the Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07142785 · 20250974