CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Modified Tarsorrhaphy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04944498
NCT04944498N/ACompleted
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Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial

Yunia Irawati·interventional·Posted Jun 29, 2021·Updated Jun 29, 2021

In Brief

A clinical study evaluating Modified Tarsorrhaphy and Gold Weight Implant for Paralytic Lagophthalmos and Leprosy--Patients. Completed, enrolled 19 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParalytic Lagophthalmos, Leprosy--Patients
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 29, 2021
Enrollment StartMay 9, 2019
Primary CompletionFeb 9, 2020
Study CompletionApr 4, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.0 years ago

Interventions

Modified Tarsorrhaphyprocedure

A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip

Gold Weight Implantprocedure

Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess