EpiRetinal Membrane Peeling and Internal Limiting Membrane

Study Overview
=================
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.

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

Conditions
-----------------
Epiretinal Membrane, Macular Pucker, Internal Limiting Membrane

Intervention / Treatment
-----------------
* Procedure: Epiretinal membrane surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILM peeling<br>ILM is peeled during epiretinal membrane surgery | Procedure: Epiretinal membrane surgery<br>* 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.<br>|
| without ILM peeling<br>ILM is not peeled during epiretinal membrane surgery | Procedure: Epiretinal membrane surgery<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epiretinal membrane, Epiretinal membrane peeling, Macular pucker, Internal limiting membrane (ILM) peeling, Pars plana vitrectomy