Clinical trial NCT03100747: Maximizing Trichiasis Surgery Success
Official title: Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
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: 2017-04-04
Enrollment: 4914
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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks
timeFrame: 6 Weeks
measure: Severity of Post-Operative Trichiasis at 6 Weeks
timeFrame: 6 Weeks
measure: Severity of Post-Operative Trichiasis at 12 Months
timeFrame: 12 Months
measure: Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks
timeFrame: 6 Weeks
measure: Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months
timeFrame: 12 Months
measure: Severity of Eyelid Contour Abnormalities at 6 Weeks
timeFrame: 6 Weeks
measure: Severity of Eyelid Contour Abnormalities at 12 Months
timeFrame: 12 Months
measure: Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year
timeFrame: 12 months
measure: Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks
timeFrame: 6 weeks
measure: Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months
timeFrame: up to 12 Months
measure: Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years
timeFrame: up to 3 Years
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: 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.