Clinical trial NCT04944498: Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients
Official title: Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralytic Lagophthalmos
Leprosy--Patients
Keywords: Hansen Disease
Leprosy
Paralytic lagophthalmos
Surgical intervention
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lagophthalmos distance without pressure
timeFrame: Pre-operative
measure: Lagophthalmos distance without pressure
timeFrame: 1 day post-operative
measure: Lagophthalmos distance without pressure
timeFrame: 7 day post-operative
measure: Lagophthalmos distance without pressure
timeFrame: 1 month post-operative
measure: Lagophthalmos distance without pressure
timeFrame: 3 months post-operative
measure: Lagophthalmos distance without pressure
timeFrame: 1 year post-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: Pre-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: 1 day post-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: 7 day post-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: 1 month post-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: 3 months post-operative
measure: Lagophthalmos distance with gentle pressure
timeFrame: 1 year post-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: Pre-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 1 day post-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 7 day post-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 1 month post-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 3 month post-operative
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 1 year post-operative
measure: TBUT (Tear Break-Up Time)
timeFrame: Pre-operative
measure: TBUT (Tear Break-Up Time)
timeFrame: 1 day post-operative
measure: TBUT (Tear Break-Up Time)
timeFrame: 7 day post-operative
measure: TBUT (Tear Break-Up Time)
timeFrame: 1 month post-operative
measure: TBUT (Tear Break-Up Time)
timeFrame: 3 months post-operative
measure: Schirmer test without anesthesia
timeFrame: Pre-operative
measure: Schirmer test without anesthesia
timeFrame: 1 day post-operative
measure: Schirmer test without anesthesia
timeFrame: 7 day post-operative
measure: Schirmer test without anesthesia
timeFrame: 1 month post-operative
measure: Schirmer test without anesthesia
timeFrame: 3 months post-operative
measure: Schirmer test without anesthesia
timeFrame: 1 year post-operative
measure: Schirmer test with anesthesia
timeFrame: Pre-operative
measure: Schirmer test with anesthesia
timeFrame: 1 day post-operative
measure: Schirmer test with anesthesia
timeFrame: 7 day post-operative
measure: Schirmer test with anesthesia
timeFrame: 1 month post-operative
measure: Schirmer test with anesthesia
timeFrame: 3 months post-operative
measure: Schirmer test with anesthesia
timeFrame: 1 year post-operative
measure: Epitheliopathy
timeFrame: Pre-operative
measure: Epitheliopathy
timeFrame: 1 day post-operative
measure: Epitheliopathy
timeFrame: 7 day post-operative
measure: Epitheliopathy
timeFrame: 1 month post-operative
measure: Epitheliopathy
timeFrame: 3 months post-operative
measure: Corneal exposure
timeFrame: Pre-operative
measure: Corneal exposure
timeFrame: 1 day post-operative
measure: Corneal exposure
timeFrame: 7 day post-operative
measure: Corneal exposure
timeFrame: 1 month post-operative
measure: Corneal exposure
timeFrame: 3 months post-operative
measure: Corneal sensibility
timeFrame: Pre-operative
measure: Corneal sensibility
timeFrame: 1 day post-operative
measure: Corneal sensibility
timeFrame: 7 day post-operative
measure: Corneal sensibility
timeFrame: 1 month post-operative
measure: Corneal sensibility
timeFrame: 3 months post-operative
measure: Complication
timeFrame: intraoperative
measure: Complication
timeFrame: 1 day post-operative
measure: Complication
timeFrame: 7 day post-operative
measure: Complication
timeFrame: 1 month post-operative
measure: Complication
timeFrame: 3 months post-operative
measure: Complication
timeFrame: 1 year post-operative
measure: Duration
timeFrame: Intraoperative
measure: Cost
timeFrame: 1 year post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: dr. Cipto Mangunkusumo Kirana Eye Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Jakarta Eye Center Hospitals and Clinics
state: DKI Jakarta
city: Makassar
country: Indonesia
facility: dr. Tadjuddin Chalid General Hospital
state: South Sulawesi
Study officials:
affiliation: Indonesia University
name: Yunia Irawati, Ophthalmologist Consultant
role: PRINCIPAL_INVESTIGATOR
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