NCT04944498

Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients

Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Yunia Irawati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the effectivity and efficiency of Modified Tarsorrhaphy (MT) technique and Gold Weight Implant (GWI) technique as a surgical treatment of paralytic lagophthalmos in leprosy patients. The hypothesis is that MT technique is more effective and more efficient than GWI technique. This study used PROBE (Prospective Randomized Open-label Blinded-Endpoint) clinical trial. Samples consisted of 14 eyes in MT group and 13 eyes in GWI group as the control group. This study was conducted in 3 hospitals in Indonesia and the patients were observed in 1 year period.

Conditions

• Paralytic Lagophthalmos
• Leprosy--Patients

Interventions

Type	Name	Description
PROCEDURE	Modified Tarsorrhaphy	A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
PROCEDURE	Gold Weight Implant	Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess

Timeline

• Start date: 2019-05-09
• Primary completion: 2020-02-09
• Completion: 2021-04-04
• First posted: 2021-06-29
• Last updated: 2021-06-29

Locations

3 sites across 1 country: Indonesia