EpiRetinal Membrane Peeling and Internal Limiting Membrane (ERMP&ILM)

To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

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.

Study Overview

• Status: Terminated
• Conditions: Epiretinal Membrane; Macular Pucker; Internal Limiting Membrane
• Intervention / Treatment: Procedure: Epiretinal membrane surgery

Detailed Description

This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.

Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.

If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.

If the ILM is partially removed, the patient is not enrolled.

The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Aura
    • Clermont-Ferrand, Aura, France, 63000
      • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult diagnosed for epiretinal surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ILM peeling; ILM is peeled during epiretinal membrane surgery	Procedure: Epiretinal membrane surgery; 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.
without ILM peeling; ILM is not peeled during epiretinal membrane surgery	Procedure: Epiretinal membrane surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA at day 15, 1, 3 month.	BCVA is measured at each medical appointment. Monoyer Scale is used and. Resulats are converted in LogMAR scale.	Day 15, Day 30, Day 90
near visual acuity measured at baseline, day 15, 1, 3 and 6 month	near visual acuity is measured at each medical appointment using Parinaud Scale	Day 180
central retinal thickness (CRT)	CRT is measured on optical coherence tomography (OCT) at baseline, day 15, 1 , 3 and 6 months	Day 180
peeling initiation retinal thickness	to evaluate the damage due to the membrane gripping during the peeling initiation, retinal thickness is performed at this location by OCT.	Day 180
10° visual field	a 10° Visual Field is performed at baseline, 1 month and 6 month	Day 180

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Isabelle Sillaire, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pars plana vitrectomy; Epiretinal membrane; Epiretinal membrane peeling; Macular pucker; Internal limiting membrane (ILM) peeling
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: RBHP 2021 SILLAIRE; 2021-A00071-40 (Other Identifier: 2021-A00071-40)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No