Epiretinal Membrane Clinical Trial
— ERMP&ILMOfficial title:
To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
Verified date | October 2023 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand | Aura |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
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 |
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