Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial (PTT)

University of North Carolina (UNC)

Status: Completed

Conditions: Surgery; Trichiasis

Treatments: Procedure: Trabut; Procedure: BRAP (Bevel/rotate/advance procedure)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03886519

UG1EY025992-04S1 (U.S. NIH Grant/Contract)

17-2766

Details and patient eligibility

About

The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.

Full description

The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.

Enrollment: 886 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or older
• At least one eyelid with post-operative upper eyelid trichiasis
• Willing to comply with all study procedures and be available for the duration of the study

Exclusion criteria

• Inability to provide independent, informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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886 participants in 2 patient groups

BRAP (Bevel/rotate/advance procedure)

Active Comparator group

Description:

The BRAP procedure is a full-thickness beveled full-thickness incision

Treatment:

Procedure: BRAP (Bevel/rotate/advance procedure)

Trabut 3 mm

Active Comparator group

Description:

The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.

Treatment:

Procedure: Trabut