Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

Study Overview
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Brief Summary
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The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.

Official Title
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Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

Conditions
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Retinal Disease, Epiretinal Membrane

Intervention / Treatment
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* Procedure: Internal Limiting Membrane Peeling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or older than 19 years Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery Exclusion Criteria: Accompanied with retinal vascular disease or intraocular inflammation Prior treatment with vitrectomy in the study eye History of glaucoma

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spontaneous ILM peeling<br> | Procedure: Internal Limiting Membrane Peeling<br>* After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.<br>|
| Active Comparator: Active ILM peeling<br> | Procedure: Internal Limiting Membrane Peeling<br>* After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.<br>|
| No Intervention: No ILM peeling<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epiretinal membrane recurrence | Recurrence of the epiretinal membrane after the surgery | 12 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity |  | 12 months after the surgery | 
| M-chart |  | 12 months after the surgery | 
| Aniseikonia |  | 12 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal limiting membrane peeling