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

Not Applicable

Completed

• Conditions: Paralytic Lagophthalmos; Leprosy--Patients

• Registration Number: NCT04944498
• Lead Sponsor: Yunia Irawati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-09
• Primary Completion: 2020-02-09
• Study Completion: 2021-04-04
• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration	Intraoperative	Duration of surgery
Cost	1 year post-operative	Cost of surgery
Lagophthalmos distance without pressure	1 year post-operative	Eyelid margin distance in central, nasal, and temporal area measured in millimeters
OSDI (Ocular Surface Disease Index)	1 year post-operative	Questionnaire assessing subjective dry eyes symptoms
TBUT (Tear Break-Up Time)	3 months post-operative	Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp
Schirmer test without anesthesia	1 year post-operative	Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test with anesthesia	1 year post-operative	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Corneal exposure	3 months post-operative	Exposed distance of cornea when the eye was closed
Epitheliopathy	3 months post-operative	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Corneal sensibility	3 months post-operative	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Complication	1 year post-operative	Complication during surgery and after surgery
Lagophthalmos distance with gentle pressure	1 year post-operative	Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Trial Locations

Locations (3)

dr. Cipto Mangunkusumo Kirana Eye Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Jakarta Eye Center Hospitals and Clinics; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

dr. Tadjuddin Chalid General Hospital; 🇮🇩 Makassar, South Sulawesi, Indonesia