This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.
The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).
120 patients will be enrolled and randomized in two groups:
* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®) * the control group "Placebo Group," with oral administration of the placebo.
Aged 18 years or older,
Scheduled to undergo surgical intervention through vitrectomy,
Aphakic or pseudophakic patients,
Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more,
Patients who have previously undergone vitrectomy for retinal detachment,
Patients with vitreous hemorrhage or any other associated retinal pathologies,
Monophthalmic patients,
Women of childbearing age without effective contraceptive methods,
Parallel
Ursolvan
Drugsingle dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.
Placebo
DrugPatients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days
Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo)
Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (Early Treatment Diabetic Retinopathy Study (ETDRS scale) between the two groups (treatment and placebo). The minimum and maximums valus : Minimum value is 6/95 equivalent in ETDRS letter score read at 4 m = 55. Maximum value is 6/6 equivalement in ETDRS letter score read at 4 m= 115. Higher score mean better ourcome
Central Nervous Epithelium (CNE) thickness
Central Nervous Epithelium (CNE) thickness, measured by SD-OCT (Spectral-Domain Optical Coherence Tomography), within the central 1mm compared to the contralateral eye in the treated group versus the placebo group (measurement adjusted to the contralateral eye to account for interindividual variability) at 1, 3, and 6 months.
Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups.
Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups.
Contrast sensitivity measurement using the Clinic CSF2.0 application.
Contrast sensitivity measurement using the Clinic CSF2.012 application (Contrast sensitivity function 2.0 application).
Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane).
Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane).
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