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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00071-40 | Other Identifier | 2021-A00071-40 |
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departure of the intern in charge of the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILM peeling | ILM is peeled during epiretinal membrane surgery |
| |
| without ILM peeling | ILM is not peeled during epiretinal membrane surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiretinal membrane surgery | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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adult diagnosed for epiretinal surgery
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Sillaire | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | AURA | 63000 | France |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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 |