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NCT04130841 Clinical Trial

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

Retinal Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04130841
Other study ID # 1901-159-1006
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date December 31, 2021

Study information
Verified date September 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 135
Est. completion date December 31, 2021
Est. primary completion date September 29, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Internal Limiting Membrane Peeling
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.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epiretinal membrane recurrence Recurrence of the epiretinal membrane after the surgery 12 months after the surgery
Secondary Best-corrected visual acuity 12 months after the surgery
Secondary M-chart 12 months after the surgery
Secondary Aniseikonia 12 months after the surgery
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