NCT04130841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

October 16, 2019

Last Update Submit

September 22, 2021

Conditions

Retinal DiseaseEpiretinal Membrane

Keywords

Internal limiting membrane peeling

Outcome Measures

Primary Outcomes (1)

  • Epiretinal membrane recurrence

    Recurrence of the epiretinal membrane after the surgery

    12 months after the surgery

Secondary Outcomes (3)

  • Best-corrected visual acuity

    12 months after the surgery

  • M-chart

    12 months after the surgery

  • Aniseikonia

    12 months after the surgery

Study Arms (3)

Spontaneous ILM peeling

EXPERIMENTAL
Procedure: Internal Limiting Membrane Peeling

Active ILM peeling

ACTIVE COMPARATOR
Procedure: Internal Limiting Membrane Peeling

No ILM peeling

NO INTERVENTION

Interventions

Internal Limiting Membrane PeelingPROCEDURE

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 ILM peelingSpontaneous ILM peeling

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or older than 19 years
  • Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery

You may not qualify if:

  • Accompanied with retinal vascular disease or intraocular inflammation
  • Prior treatment with vitrectomy in the study eye
  • History of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Retinal DiseasesEpiretinal Membrane

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Un Chul Park

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 17, 2019

Study Start

September 30, 2019

Primary Completion

September 29, 2021

Study Completion

December 31, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)