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Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery — UDCA  

Retinal Detachment Clinical Trial

Official title:
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06294847
Study type Interventional
Source Hopital Foch
Contact BEHAR COHEN Francinbe
Phone 01 46 25 22 75
Email f.behar-cohen@hopital-foch.com
Status Not yet recruiting
Phase Phase 3
Start date April 2024
Completion date October 2027
View Details
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