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EpiRetinal Membrane Peeling and Internal Limiting Membrane

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04802265
Acronym
ERMP&ILM
Enrollment
10
Registered
2021-03-17
Start date
2021-05-21
Completion date
2021-08-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Internal Limiting Membrane, Macular Pucker

Keywords

Epiretinal membrane, Epiretinal membrane peeling, Macular pucker, Internal limiting membrane (ILM) peeling, Pars plana vitrectomy

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.

Interventions

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuity (BCVA) (metric : LogMAR)prior to surgeryBCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026