NCT04802265

Brief Summary

To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 10, 2021

Last Update Submit

October 19, 2023

Conditions

Epiretinal MembraneMacular PuckerInternal Limiting Membrane

Keywords

Epiretinal membraneEpiretinal membrane peelingMacular puckerInternal limiting membrane (ILM) peelingPars plana vitrectomy

Outcome Measures

Primary Outcomes (2)

  • Best corrected visual acuity (BCVA) (metric : LogMAR)

    BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.

    prior to surgery

  • Best corrected visual acuity (BCVA) (metric : LogMAR)

    BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.

    Day 180

Secondary Outcomes (5)

  • BCVA at day 15, 1, 3 month.

    Day 15, Day 30, Day 90

  • near visual acuity measured at baseline, day 15, 1, 3 and 6 month

    Day 180

  • central retinal thickness (CRT)

    Day 180

  • peeling initiation retinal thickness

    Day 180

  • 10° visual field

    Day 180

Study Arms (2)

ILM peeling

ILM is peeled during epiretinal membrane surgery

Procedure: Epiretinal membrane surgery

without ILM peeling

ILM is not peeled during epiretinal membrane surgery

Procedure: Epiretinal membrane surgery

Interventions

Epiretinal membrane surgeryPROCEDURE

The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification. An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser.

ILM peelingwithout ILM peeling

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult diagnosed for epiretinal surgery

You may qualify if:

  • adult up to 18 years old,
  • diagnosed and treated surgically

You may not qualify if:

  • proliferative diabetic retinopathy,
  • ocular trauma,
  • central veinous occlusion,
  • intra-ocular tumor, total retinal detachment,
  • central visual field loss in glaucomatous patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, AURA, 63000, France

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Isabelle Sillaire

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 17, 2021

Study Start

May 21, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

FR(1)