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

NCT07322302 | Recruiting DMC

• 2 other identifiers: 24-29571UG1EY036891
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 2

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

Keywords

Surgery; Oculoplastics; trichiasis; trachoma

Outcome Measures

Primary Outcomes (1)

• Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months 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 Outcomes (5)

• Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)

  Assessed at last study visit (max: 2 years)

• Number of eyelids with clinically significant rPTT by twelve months

  >2 weeks and up to 12 months after surgery

• Number of eyelids with rPTT by 24 months

  Between two weeks and twenty four months after surgery

• Number of eyelids with each level of rPTT Severity

  At first visit where rPTT is detected (up to 2 years after surgery)

• Cumulative number of eyelids with pyogenic granuloma

  Any time between surgery and 24 months after surgery

Study Arms (2)

Bevel/rotate/advance procedure (B-RAP)

EXPERIMENTAL

Trichiasis surgery using the B-RAP procedure.

Procedure: B-RAP

Bilamellar tarsal rotation (BLTR)

ACTIVE COMPARATOR

Trichiasis surgery using the BLTR procedure.

Procedure: BLTR

Interventions

B-RAP PROCEDURE

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.

Bevel/rotate/advance procedure (B-RAP)

BLTR PROCEDURE

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.

Bilamellar tarsal rotation (BLTR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• All eyes with previously operated trichiasis that are phthisical

Sponsors & Collaborators

• University of Virginia: collaborator
• University of Pennsylvania: collaborator
• Kongwa Trachoma Project: collaborator
• National Eye Institute (NEI): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Kongwa Trachoma Project

Mtwara, Tanzania

RECRUITING

Related Publications (14)

• Kello AB, Merbs SL, Resnikoff S, West S, Mariotti SP, Solomon A. Trichiasis Surgery for Trachoma. 3rd ed. World Health Organization; 2024:80.

  BACKGROUND

• Habtamu E, Wondie T, Aweke S, Tadesse Z, Zerihun M, Gashaw B, Roberts CH, Kello AB, Mabey DCW, Rajak SN, Callahan EK, Macleod D, Weiss HA, Burton MJ. Oral doxycycline for the prevention of postoperative trachomatous trichiasis in Ethiopia: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2018 May;6(5):e579-e592. doi: 10.1016/S2214-109X(18)30111-6.

  PMID: 29653629 BACKGROUND

• Habtamu E, Wondie T, Aweke S, Tadesse Z, Zerihun M, Zewudie Z, Kello AB, Roberts CH, Emerson PM, Bailey RL, Mabey DC, Rajak SN, Callahan K, Weiss HA, Burton MJ. Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis in Ethiopia: a randomised controlled trial. Lancet Glob Health. 2016 Mar;4(3):e175-84. doi: 10.1016/S2214-109X(15)00299-5. Epub 2016 Jan 14.

  PMID: 26774708 BACKGROUND

• Burton MJ, Kinteh F, Jallow O, Sillah A, Bah M, Faye M, Aryee EA, Ikumapayi UN, Alexander ND, Adegbola RA, Faal H, Mabey DC, Foster A, Johnson GJ, Bailey RL. A randomised controlled trial of azithromycin following surgery for trachomatous trichiasis in the Gambia. Br J Ophthalmol. 2005 Oct;89(10):1282-8. doi: 10.1136/bjo.2004.062489.

  PMID: 16170117 BACKGROUND

• Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial. PLoS Med. 2011 Dec;8(12):e1001137. doi: 10.1371/journal.pmed.1001137. Epub 2011 Dec 13.

  PMID: 22180732 BACKGROUND

• West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14. doi: 10.1001/archopht.124.3.309.

  PMID: 16534049 BACKGROUND

• Gower EW, West SK, Harding JC, Cassard SD, Munoz BE, Othman MS, Kello AB, Merbs SL. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial. JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.

  PMID: 23494035 BACKGROUND

• Khandekar R, Mohammed AJ, Courtright P. Recurrence of trichiasis: a long-term follow-up study in the Sultanate of Oman. Ophthalmic Epidemiol. 2001 Jul;8(2-3):155-61. doi: 10.1076/opep.8.2.155.4165.

  PMID: 11471085 BACKGROUND

• Khandekar R, Thanh TT, Luong VQ. The determinants of trichiasis recurrence differ at one and two years following lid surgery in Vietnam: A community-based intervention study. Oman J Ophthalmol. 2009 Sep;2(3):119-25. doi: 10.4103/0974-620X.57311.

  PMID: 20927208 BACKGROUND

• Gower EW, Sisay A, Bayissasse B, Seyum D, Weaver J, Munoz B, Keil AP, Bankoski A, Sullivan KM, Kana H, Admassu F, Tadesse D, Merbs SL. The impact of modified incision height and surgical procedure on trichiasis surgery outcomes: Results of the maximizing trichiasis surgery success (MTSS) randomized trial. PLoS Negl Trop Dis. 2024 Sep 3;18(9):e0012034. doi: 10.1371/journal.pntd.0012034. eCollection 2024 Sep.

  PMID: 39226693 BACKGROUND

• Courtright P, Gower EW, Kello AB, Solomon AW. Second Global Scientific Meeting on Trachomatous Trichiasis, Cape Town 4-6 November 2015. (Solomon A, ed.). World Health Organization; 2016.

  BACKGROUND

• Merbs SL, Talero SL, Tadesse D, Sisay A, Bayissasse B, Weaver JU, Gower EW. A New Surgical Technique for Postoperative Trachomatous Trichiasis. Ophthalmic Plast Reconstr Surg. 2021 Nov-Dec 01;37(6):595-598. doi: 10.1097/IOP.0000000000002055.

  PMID: 34570049 BACKGROUND

• Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.

  PMID: 22745845 BACKGROUND

• Kamuyu MK, Kelly M, Somerville S. A secondary analysis to determine countries and districts eligible for documented full geographic coverage for trichiasis case finding and outreaches. Int Health. 2023 Dec 4;15(15 Suppl 2):ii53-ii57. doi: 10.1093/inthealth/ihad075.

  PMID: 38048374 BACKGROUND

MeSH Terms

Conditions

Trachoma; Eye Diseases; Trichiasis

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Eyelid Diseases

Study Officials

• Emily Gower, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Gower, PhD

CONTACT

919 966 1420; egower@unc.edu

Jerusha Weaver, MPH

CONTACT

919 966 3527; jweave25@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome examiners will be masked to treatment assignment. Field-based outcomes will be assessed in the field by masked outcome examiners (e.g. presence of rPTT, granuloma), and photograph-based outcomes (e.g., ECA) will be graded centrally at the data coordinating center in a masked fashion. Given the nature of the study, surgeons will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization at the person level, stratified by surgeon and baseline PTT severity (mild vs severe)

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified individual data that support the results will be shared beginning 9 and continuing for 36 months following publication.
• 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.

Locations

US (1); TA (1)