EpiRetinal Membrane Peeling and Internal Limiting Membrane

Epiretinal Membrane Clinical Trial

— ERMP&ILM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04802265
• Other study ID #: RBHP 2021 SILLAIRE
• Secondary ID: 2021-A00071-40
• Status: Terminated
• Start date: May 21, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Internal Limiting Membrane
• Macular Pucker

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Aura

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	central retinal thickness (CRT)	CRT is measured on optical coherence tomography (OCT) at baseline, day 15, 1 , 3 and 6 months	Day 180
Secondary	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
Secondary	10° visual field	a 10° Visual Field is performed at baseline, 1 month and 6 month	Day 180