RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Repeat Eyelid Surgery for Trichiasis: Optimizing Results in East Africa (RESTORE): A Randomized Controlled Trial Comparing Two Surgical Techniques for Repeat Trichiasis Surgery Performed by Integrated Eye Care Workers
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- B-RAP (procedure)
- BLTR (procedure)
Sponsor: University of North Carolina, Chapel Hill · Participants: 1,000 · Started: Jan 13, 2026
Contact the study team
- Emily Gower, PhD · Phone: 919 966 1420
- Jerusha Weaver, MPH · Phone: 919 966 3527
Official record on ClinicalTrials.gov — NCT07322302
Locations in the U.S.
| North Carolina | University of North Carolina, Chapel Hill |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.