Epiretinal Membrane, Internal Limiting Membrane, Macular Pucker
Conditions
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France