NCT03100747

Maximizing Trichiasis Surgery Success

Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,914 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trichiasis
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Bilamellar 3 mm	Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
PROCEDURE	Bilamellar 5 mm	Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
PROCEDURE	Trabut 3 mm	Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin

Timeline

• Start date: 2017-04-05
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2017-04-04
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

1 site across 1 country: Ethiopia