Clinical Trial

RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)

Recruiting
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-14
Trial Details
NCT Number NCT07322302
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: University of Virginia, University of Pennsylvania, Kongwa Trachoma Project, National Eye Institute (NEI)
Conditions Trachoma, Eye Diseases, Trichiasis
Enrollment 1,000 participants
Start Date 2026-01-13
Primary Completion 2029-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13