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

Primary Purpose

Retinal Disease, Epiretinal Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Internal Limiting Membrane Peeling
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Disease focused on measuring Internal limiting membrane peeling

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Spontaneous ILM peeling

Active ILM peeling

No ILM peeling

Arm Description

Outcomes

Primary Outcome Measures

Epiretinal membrane recurrence
Recurrence of the epiretinal membrane after the surgery

Secondary Outcome Measures

Best-corrected visual acuity
M-chart
Aniseikonia

Full Information

First Posted
October 16, 2019
Last Updated
September 22, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04130841
Brief Title
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
Official Title
Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 29, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Epiretinal Membrane
Keywords
Internal limiting membrane peeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spontaneous ILM peeling
Arm Type
Experimental
Arm Title
Active ILM peeling
Arm Type
Active Comparator
Arm Title
No ILM peeling
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Internal Limiting Membrane Peeling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epiretinal membrane recurrence
Description
Recurrence of the epiretinal membrane after the surgery
Time Frame
12 months after the surgery
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity
Time Frame
12 months after the surgery
Title
M-chart
Time Frame
12 months after the surgery
Title
Aniseikonia
Time Frame
12 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Un Chul Park
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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