MedTrace Logo

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

NCT07322302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

  • University of Virginia

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Kongwa Trachoma Project

    collaborator UNKNOWN

  • National Eye Institute (NEI)

    collaborator NIH

Principal Investigators

  • Emily Gower, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • United States
  • Tanzania

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07322302 on ClinicalTrials.gov