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Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jakarta Eye Center Hospitals and Clinics
Jakarta, DKI Jakarta, Indonesia
dr. Cipto Mangunkusumo Kirana Eye Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
dr. Tadjuddin Chalid General Hospital
Makassar, South Sulawesi, Indonesia
Start Date
May 9, 2019
Primary Completion Date
February 9, 2020
Completion Date
April 4, 2021
Last Updated
June 29, 2021
19
ACTUAL participants
Modified Tarsorrhaphy
PROCEDURE
Gold Weight Implant
PROCEDURE
Lead Sponsor
Yunia Irawati
NCT06291818
NCT07448389
Data Source & Attribution
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