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

Not Applicable

• Conditions: Epiretinal Membrane; Retinal Disease
• Interventions: Procedure: Internal Limiting Membrane Peeling

• Registration Number: NCT04130841
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23
• Primary Completion: 2021-09-29
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Spontaneous ILM peeling	Internal Limiting Membrane Peeling	-
Active ILM peeling	Internal Limiting Membrane Peeling	-

Primary Outcome Measures

Name	Time	Method
Epiretinal membrane recurrence	12 months after the surgery	Recurrence of the epiretinal membrane after the surgery

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	12 months after the surgery
M-chart	12 months after the surgery
Aniseikonia	12 months after the surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of