NCT03886519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
886

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

April 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 22, 2024

Completed
Last Updated

February 22, 2024

Status Verified

August 1, 2022

Enrollment Period

3.5 years

First QC Date

March 20, 2019

Results QC Date

January 22, 2024

Last Update Submit

February 20, 2024

Conditions

TrichiasisSurgery

Outcome Measures

Primary Outcomes (1)

  • Number of Eyelids With Post-operative Trichiasis Within 12 Months

    Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.

    10-20 months

Secondary Outcomes (7)

  • Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months

    3-6 months

  • Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months

    3-6 months

  • Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months

    10-20 months

  • Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System

    10-20 months

  • Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months

    3-6 months

  • +2 more secondary outcomes

Study Arms (2)

BRAP (Bevel/rotate/advance procedure)

ACTIVE COMPARATOR

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

Procedure: BRAP (Bevel/rotate/advance procedure)

Trabut 3 mm

ACTIVE COMPARATOR

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.

Procedure: Trabut

Interventions

BRAP (Bevel/rotate/advance procedure)PROCEDURE

Trichiasis surgery using the BRAP procedure

Also known as: BRAP procedure
BRAP (Bevel/rotate/advance procedure)
TrabutPROCEDURE

Trichiasis surgery using the Trabut procedure

Also known as: Trabut procedure
Trabut 3 mm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide independent, informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orbis Ethiopia

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

Location

Related Publications (1)

  • Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.

    PMID: 22745845BACKGROUND

MeSH Terms

Conditions

Trichiasis

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Inosine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

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

March 20, 2019

First Posted

March 22, 2019

Study Start

April 13, 2019

Primary Completion

October 22, 2022

Study Completion

October 22, 2022

Last Updated

February 22, 2024

Results First Posted

February 22, 2024

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication.
Access Criteria
An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Locations

ET(1)