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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

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

1,000 Participants
are divided into 2 treatment groups

Sponsors 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