About this trial
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
Qualifiers
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
Disqualifiers
Unable to provide informed consent
All eyes with previously operated trichiasis that are phthisical
Trial design
Treatments tested in this trial
- B-RAP
- BLTR
Treatment groups
Locations
2Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
University of Virginia
Collaborator
University of Pennsylvania
Collaborator
Kongwa Trachoma Project
Collaborator
National Eye Institute (NEI)
Collaborator