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.
Protocol Amendment History
3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-28; most recent amendment 2025-05-12.
Status change: Not Yet Recruiting → Recruiting2025-05-12