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

University of North Carolina (UNC)

Status: Not yet enrolling

Conditions: Trichiasis; Eye Diseases; Trachoma

Treatments: Procedure: BLTR; Procedure: B-RAP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07322302

24-2957

1UG1EY036891 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

Bevel/rotate/advance procedure (B-RAP)

Experimental group

Description:

Trichiasis surgery using the B-RAP procedure.

Treatment:

Procedure: B-RAP

Bilamellar tarsal rotation (BLTR)

Active Comparator group

Description:

Trichiasis surgery using the BLTR procedure.

Treatment:

Procedure: BLTR