Status:
RECRUITING
Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Surgery for Cataract
Surgery for and Idiopathic Epiretinal Membrane
Eligibility:
All Genders
40+ years
Brief Summary
The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6 to 19%. Even though most cases show very few symptomats, they may induce alterations of the underlying retin...
Eligibility Criteria
Inclusion
- Patients presenting idiopathic ERM visible on SD-OCT;
- Indication for combined cataract and ERM surgery in a context of a fall in visual acuity or disabling metamorphopsia;
- Patients who have provided verbal consent;
- Age ≥ 40 years.
Exclusion
- Patients with secondary ERM (Diabetes WITH a history of diabetic retinopathy or maculopathy, occlusion of the retinal veins, uveitis intermediate/posterior uveitis or retinal tear/detachment in the studied eye;
- Patient présentant toute autre maculopathie ou neuropathie optique ;
- Patient presenting severe myopia (spherical equivalent ≥ 6 diopters or axial length ≥ 26 mm) ;
- Patients presenting any other ophthalmological disease independent of the ERM and likely to limit visual acuity
- Patients who have already undergone vitrectomy in the studied eye;
- Non-visible or poorly visible fundus due to a cloudy vitreous (Signal on OCT Cirrus \<5, Quality score on OCT Spectralis \< 20, signal trend index on OCT Optovue \< 30)
- Patients without national health insurance cover
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03329976
Start Date
April 3 2018
End Date
October 1 2026
Last Update
March 28 2024
Active Locations (1)
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1
CHU Dijon Bourgogne
Dijon, France, 21079