Clinical trial NCT03886519: Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Official title: Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichiasis
Surgery
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Orbis
name: National Eye Institute (NEI)
name: University of Maryland, Baltimore
First posted: 2019-03-22
Enrollment: 886
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Eyelids With Post-operative Trichiasis Within 12 Months
timeFrame: 10-20 months
Secondary outcomes:
measure: Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months
timeFrame: 3-6 months
measure: Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
timeFrame: 3-6 months
measure: Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
timeFrame: 10-20 months
measure: Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
timeFrame: 10-20 months
measure: Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
timeFrame: 3-6 months
measure: Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
timeFrame: 10-20 months
measure: Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months
timeFrame: 10-20 months
Other outcomes:
Locations:
city: Hosa'ina
country: Ethiopia
facility: Orbis Ethiopia
state: Southerns Nations, Nationalities, And Peoples' Region
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily Gower, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.