ERMP&ILM: EpiRetinal Membrane Peeling and Internal Limiting Membrane
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Best corrected visual acuity (BCVA) (metric : LogMAR) [prior to surgery]
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
- 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
- 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.
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Clermont-Ferrand | Clermont-Ferrand | Aura | France | 63000 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
Investigators
- Principal Investigator: Isabelle Sillaire, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RBHP 2021 SILLAIRE
- 2021-A00071-40