Maximizing Trichiasis Surgery Success — MTSS  

Surgery Clinical Trial

Official title: Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Surgery
• Trichiasis

• NCT number: NCT03100747
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Completion date: June 2, 2022