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

April 9, 2026 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will randomize 1000 individuals with post-operative trichiasis on a 1:1 basis to standard BLTR surgery or the recently developed Bevel-Rotate Advancement Procedure (B-RAP). Participants will receive trichiasis surgery and will be followed at 1 day, 2 weeks and 3, 6, 9 12, 18 and 24 months after surgery. The primary outcome is development of repeat post-operative trachomatous trichiasis (rPTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT between the two procedures, controlling for demographic characteristics and pre-operative trichiasis severity.

Secondary outcomes include pyogenic granuloma formation and eyelid contour abnormalities as well as patient-reported outcomes.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emily Gower, PhD
  • Phone Number: 919 966 1420
  • Email: egower@unc.edu

Study Contact Backup

Study Locations

  • Tanzania
      • Mtwara, Tanzania
        • Recruiting
        • Kongwa Trachoma Project
        • Contact:
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Emily Gower, PhD
        • Sub-Investigator:
          • Shannath Merbs, MD, PhD
        • Sub-Investigator:
          • Gui-shuang Ying, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevel/rotate/advance procedure (B-RAP)
Trichiasis surgery using the B-RAP procedure.
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.
Active Comparator: Bilamellar tarsal rotation (BLTR)
Trichiasis surgery using the BLTR procedure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
>2 weeks after surgery to one year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)
Time Frame: Assessed at last study visit (max: 2 years)

The grader will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. Results will be based on photograph grades.

Category definitions are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Assessed at last study visit (max: 2 years)
Number of eyelids with clinically significant rPTT by twelve months
Time Frame: >2 weeks and up to 12 months after surgery
Presence of clinically significant rPTT is defined as evidence of entropion AND either 1) >2 lashes touching the eye peripherally (Not touching the cornea in primary gaze) or 2) at least one eyelash emanating from the central portion of the eyelid, touching the cornea in primary gaze. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
>2 weeks and up to 12 months after surgery
Number of eyelids with rPTT by 24 months
Time Frame: Between two weeks and twenty four months after surgery
Presence of repeat post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9, 12, 18 and 24 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.
Between two weeks and twenty four months after surgery
Number of eyelids with each level of rPTT Severity
Time Frame: At first visit where rPTT is detected (up to 2 years after surgery)

Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.

Trichiasis severity will be defined using the following categories:

  • i. Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe
  • ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated
  • iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe)
At first visit where rPTT is detected (up to 2 years after surgery)
Cumulative number of eyelids with pyogenic granuloma
Time Frame: Any time between surgery and 24 months after surgery
Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3, 6, 9, 12, 18 and 24 month visit s(including participants where the granuloma was removed)
Any time between surgery and 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of Pennsylvania
National Eye Institute (NEI)
University of Virginia
Kongwa Trachoma Project

Investigators

  • Principal Investigator: Emily Gower, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-2957
  • 1UG1EY036891 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.

IPD Sharing Time Frame

Deidentified individual data that support the results will be shared beginning 9 and continuing for 36 months following publication.

IPD Sharing Access Criteria

An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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