RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Recruiting now · Not applicable
Conditions studied: Trachoma, Eye Diseases, Trichiasis
In brief
The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with Bevel-Rotate Advancement Procedure (B-RAP) improves surgical success compared to Bilamellar Tarsal Rotation (BLTR) among a group of 8-10 TT surgeons in Tanzania. The study aims to enroll 1,000 individuals with PTT. The primary outcome is repeat PTT within one year after surgery. Additionally, the study will assess eyelid contour abnormalities and how they change over a two-year period as well as patient reported outcomes. If this project is successful in improving surgical outcomes, it could change the approach to treating PTT globally. Individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members' quality of life considerably.
Key facts
- Study ID
- NCT07322302
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 1000
- Starts
- 2026-01-13
- Expected to finish
- 2029-08-31
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One or both eyes with upper eyelid PTT, with a plan to undergo PTT surgery
- Previous upper eyelid TT surgery in the study eye(s)
- Collection of all baseline data prior to randomization
- Signed, informed consent
You may not qualify if…
- Unable to provide informed consent
- All eyes with previously operated trichiasis that are phthisical
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
- Kongwa Trachoma Project — Mtwara, Tanzania (enrolling)
Full record on ClinicalTrials.gov
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