Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-02-28
Brief Title:
Ursodeoxycholic Acid UDCA as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Ursodeoxycholic Acid UDCA as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UDCA
Brief 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 ie 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
The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None