Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-13

Study Completion Date

2022-10-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trichiasis Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BRAP (Bevel/rotate/advance procedure)

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

Group Type ACTIVE_COMPARATOR

BRAP (Bevel/rotate/advance procedure)

Intervention Type PROCEDURE

Trichiasis surgery using the BRAP procedure

Trabut 3 mm

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.

Group Type ACTIVE_COMPARATOR

Trabut

Intervention Type PROCEDURE

Trichiasis surgery using the Trabut procedure

Interventions

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BRAP (Bevel/rotate/advance procedure)

Trichiasis surgery using the BRAP procedure

Intervention Type PROCEDURE

Trabut

Trichiasis surgery using the Trabut procedure

Intervention Type PROCEDURE

Other Intervention Names

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BRAP procedure Trabut procedure

Eligibility Criteria

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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