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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04130841

Collaborator

(none)

135

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Disease Epiretinal Membrane	Procedure: Internal Limiting Membrane Peeling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Sep 29, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spontaneous ILM peeling	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.
Active Comparator: Active ILM peeling	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.
No Intervention: No ILM peeling

Arm

Intervention/Treatment

Experimental: Spontaneous ILM peeling

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.

Active Comparator: Active ILM peeling

Procedure: Internal Limiting Membrane Peeling

No Intervention: No ILM peeling

Outcome Measures

Primary Outcome Measures

Epiretinal membrane recurrence [12 months after the surgery]
Recurrence of the epiretinal membrane after the surgery

Secondary Outcome Measures

Best-corrected visual acuity [12 months after the surgery]
M-chart [12 months after the surgery]
Aniseikonia [12 months after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Un Chul Park, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Un Chul Park, Associate Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04130841

Other Study ID Numbers:

1901-159-1006

First Posted:

Oct 17, 2019

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Un Chul Park, Associate Professor, Seoul National University Hospital

Internal limiting membrane peeling

Additional relevant MeSH terms:

Retinal Diseases

Epiretinal Membrane

Study Results

No Results Posted as of Sep 23, 2021