Maximizing Trichiasis Surgery Success

NCT03100747 | Completed Results DMC

• 2 other identifiers: 16-2878UG1EY025992
• Study Type: interventional
• Target: 4,914
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trichiasis; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months

  Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.

  12 Months

Secondary Outcomes (11)

• Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks

  6 Weeks

• Severity of Post-Operative Trichiasis at 6 Weeks

  6 Weeks

• Severity of Post-Operative Trichiasis at 12 Months

  12 Months

• Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks

  6 Weeks

• Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months

  12 Months

Study Arms (3)

Bilamellar 3 mm

ACTIVE COMPARATOR

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.

Procedure: Bilamellar 3 mm

Bilamellar 5mm

ACTIVE COMPARATOR

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.

Procedure: Bilamellar 5 mm

Trabut 3mm

ACTIVE COMPARATOR

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.

Procedure: Trabut 3 mm

Interventions

Bilamellar 3 mm PROCEDURE

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

Also known as: Bilamellar Tarsal Rotation with 3 mm incision

Bilamellar 3 mm

Bilamellar 5 mm PROCEDURE

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

Also known as: Bilamellar Tarsal Rotation with 5mm incision

Bilamellar 5mm

Trabut 3 mm PROCEDURE

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

Also known as: Trabut procedure with 3 mm incision

Trabut 3mm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Inability to provide independent, informed consent
• All eyes with previously unoperated trichiasis are phthisical

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Orbis: collaborator
• National Eye Institute (NEI): collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Orbis Ethiopia

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

Location

Related Publications (3)

• 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 DERIVED

• 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.

  PMID: 37757880 DERIVED

• 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.

  PMID: 32193277 DERIVED

MeSH Terms

Conditions

Trichiasis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Emily Gower, PhD
• Organization: University of North Carolina at Chapel Hill

egower@unc.edu

919-966-1420

Study Officials

• Emily Gower, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: April 4, 2017
• Study Start: April 5, 2017
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

ET (1)