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

Yunia Irawati

Status: Completed

Conditions: Leprosy--Patients; Paralytic Lagophthalmos

Treatments: Procedure: Gold Weight Implant; Procedure: Modified Tarsorrhaphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04944498

KE/FK/0525/EC/2019

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• paucibacillary (PB) or multibacillary (MB) type leprosy patient with unilateral/bilateral lagophthalmos who had not undergone eyelid reconstruction
• patient aged 18 years old or older who could be performed surgery with local anesthesia

Exclusion criteria

• patient with acute leprosy reaction (<6 months) and in steroid medication
• patient with eyelid laxity >8 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients who received surgery with modified tarsorrhaphy technique

Treatment:

Procedure: Modified Tarsorrhaphy

Control group

Active Comparator group

Description:

Patients who received surgery with gold weight implant technique

Treatment:

Procedure: Gold Weight Implant