protocolSection identificationModule nctId: NCT06294847, orgStudyIdInfo id: 2021_0025, briefTitle: Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery, acronym: UDCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hopital Foch, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Retinal Detachment, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Ursolvan, interventions name: Placebo, outcomesModule primaryOutcomes measure: 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), secondaryOutcomes measure: Central Nervous Epithelium (CNE) thickness, secondaryOutcomes measure: Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups., secondaryOutcomes measure: Contrast sensitivity measurement using the Clinic CSF2.0 application., secondaryOutcomes measure: Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane)., secondaryOutcomes measure: Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants)., secondaryOutcomes measure: Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE., secondaryOutcomes measure: Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT., secondaryOutcomes measure: Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity., secondaryOutcomes measure: Presence of metamorphopsia., secondaryOutcomes measure: Tolerance and occurrence of adverse events., secondaryOutcomes measure: National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative., secondaryOutcomes measure: Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times., secondaryOutcomes measure: Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Cochin, city: Paris, zip: 75014, country: France, contacts name: EYMARD Pauline, Dr, role: CONTACT, email: pauline.eymard@aphp.fr, contacts name: EYMARD Pauline, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Foch, city: Suresnes, zip: 92150, country: France, contacts name: Behar Cohen Francine, Pr, role: CONTACT, phone: 01 46 25 22 75, email: .behar-cohen@hopital-foch.com, contacts name: Behar Cohen Francine, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.87143, lon: 2.22929, hasResults: False