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Maximizing Trichiasis Surgery Success

NCT ID: NCT03100747

Last Updated: 2023-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2022-06-02

Brief Summary

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The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.

Detailed Description

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In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.

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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Bilamellar 3 mm

Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin.

Group Type ACTIVE_COMPARATOR

Bilamellar 3 mm

Intervention Type PROCEDURE

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin

Bilamellar 5mm

Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin.

Group Type ACTIVE_COMPARATOR

Bilamellar 5 mm

Intervention Type PROCEDURE

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin

Trabut 3mm

Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin.

Group Type ACTIVE_COMPARATOR

Trabut 3 mm

Intervention Type PROCEDURE

Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin

Interventions

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Bilamellar 3 mm

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin

Intervention Type PROCEDURE

Bilamellar 5 mm

Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin

Intervention Type PROCEDURE

Trabut 3 mm

Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin

Intervention Type PROCEDURE

Other Intervention Names

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Bilamellar Tarsal Rotation with 3 mm incision Bilamellar Tarsal Rotation with 5mm incision Trabut procedure with 3 mm incision

Eligibility Criteria

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Inclusion Criteria

* At least one eyelid with previously unoperated 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
* All eyes with previously unoperated trichiasis are phthisical
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orbis

OTHER

Sponsor Role collaborator

National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Gower, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Orbis Ethiopia

Hosa’ina, Southerns Nations, Nationalities, and Peoples' Region, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 39226693 (View on PubMed)

Diallo AO, Bayissasse B, Sisay A, Seyum D, Weaver J, Munoz B, Merbs SL, Gower EW. Effectiveness of Trachomatous Trichiasis Case-identification Approaches in Ethiopia. Epidemiology. 2023 Nov 1;34(6):909-920. doi: 10.1097/EDE.0000000000001656. Epub 2023 Sep 26.

Reference Type DERIVED
PMID: 37757880 (View on PubMed)

Bayissasse B, Sullivan KM, Merbs SL, Munoz B, Keil A, Sisay A, Singer A, Gower EW. Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes. BMJ Open. 2020 Mar 18;10(3):e036327. doi: 10.1136/bmjopen-2019-036327.

Reference Type DERIVED
PMID: 32193277 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UG1EY025992

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-2878

Identifier Type: -

Identifier Source: org_study_id