Recruiting

B-RAP & BLTR

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07322302

Conditions

Trachoma

Eye Diseases

Trichiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

B-RAP

BLTR

Study Details

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.

Conditions

Trachoma

Eye Diseases

Trichiasis

Study ID

NCT07322302

Start date

Jan 13, 2026

Status verified date

Dec, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bevel/rotate/advance procedure (B-RAP)

Trichiasis surgery using the B-RAP procedure.

active comparator: Bilamellar tarsal rotation (BLTR)

Trichiasis surgery using the BLTR procedure.

Interventions

B-RAP

B-RAP uses an incision beveled toward the eyelashes to thin the distal fragment and allow access to and removal of scarring from previous surgery. The distal fragment is rotated and the tarsus and conjunctiva are advanced downward to further correct the PTT.

BLTR

A full-thickness incision is made through the anterior and posterior lamellae, parallel to and 3mm above the lid margin. Three sutures are placed externally to rotate and fix the eyelid.

Primary outcome measure

  • Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months after surgery [ Time Frame: >2 weeks after surgery to one year after surgery ]

Central Contacts and Locations

Central contacts

Emily Gower, PhD

919 966 1420egower@unc.edu

Jerusha Weaver, MPH

919 966 3527jweave25@unc.edu

Locations

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Emily Gower, PhD

443-690-7653egower@unc.edu

Principal Investigator:

Emily Gower, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 13, 2026

Last verified

Dec, 2025

Keywords

  • Surgery
  • Oculoplastics
  • trichiasis
  • trachoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-13.