NCT07322302 RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
| NCT ID | NCT07322302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Trachoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2029-08-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unable to provide informed consent * All eyes with previously operated trichiasis that are phthisical