EpiRetinal Membrane Peeling and Internal Limiting Membrane

Terminated

• Conditions: Macular Pucker; Internal Limiting Membrane; Epiretinal Membrane
• Interventions: Procedure: Epiretinal membrane surgery

• Registration Number: NCT04802265
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-17
• Study Start: 2021-05-21
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
without ILM peeling	Epiretinal membrane surgery	ILM is not peeled during epiretinal membrane surgery
ILM peeling	Epiretinal membrane surgery	ILM is peeled during epiretinal membrane surgery

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA) (metric : LogMAR)	Day 180	BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Aura, France