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

Study Overview
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Brief Summary
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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.

Official Title
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Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial

Conditions
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Paralytic Lagophthalmos, Leprosy--Patients

Intervention / Treatment
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* Procedure: Modified Tarsorrhaphy
* Procedure: Gold Weight Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients who received surgery with modified tarsorrhaphy technique | Procedure: Modified Tarsorrhaphy<br>* A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip<br>|
| Active Comparator: Control group<br>Patients who received surgery with gold weight implant technique | Procedure: Gold Weight Implant<br>* Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | Pre-operative | 
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | 1 day post-operative | 
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | 7 day post-operative | 
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | 1 month post-operative | 
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | 3 months post-operative | 
| Lagophthalmos distance without pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters | 1 year post-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | Pre-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | 1 day post-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | 7 day post-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | 1 month post-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | 3 months post-operative | 
| Lagophthalmos distance with gentle pressure | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid | 1 year post-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | Pre-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | 1 day post-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | 7 day post-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | 1 month post-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | 3 month post-operative | 
| OSDI (Ocular Surface Disease Index) | Questionnaire assessing subjective dry eyes symptoms | 1 year post-operative | 
| TBUT (Tear Break-Up Time) | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp | Pre-operative | 
| TBUT (Tear Break-Up Time) | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp | 1 day post-operative | 
| TBUT (Tear Break-Up Time) | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp | 7 day post-operative | 
| TBUT (Tear Break-Up Time) | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp | 1 month post-operative | 
| TBUT (Tear Break-Up Time) | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp | 3 months post-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | Pre-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | 1 day post-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | 7 day post-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | 1 month post-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | 3 months post-operative | 
| Schirmer test without anesthesia | Tear film excretion examined using Whatman filter paper without anesthesia | 1 year post-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | Pre-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | 1 day post-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | 7 day post-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | 1 month post-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | 3 months post-operative | 
| Schirmer test with anesthesia | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination | 1 year post-operative | 
| Epitheliopathy | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp | Pre-operative | 
| Epitheliopathy | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp | 1 day post-operative | 
| Epitheliopathy | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp | 7 day post-operative | 
| Epitheliopathy | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp | 1 month post-operative | 
| Epitheliopathy | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp | 3 months post-operative | 
| Corneal exposure | Exposed distance of cornea when the eye was closed | Pre-operative | 
| Corneal exposure | Exposed distance of cornea when the eye was closed | 1 day post-operative | 
| Corneal exposure | Exposed distance of cornea when the eye was closed | 7 day post-operative | 
| Corneal exposure | Exposed distance of cornea when the eye was closed | 1 month post-operative | 
| Corneal exposure | Exposed distance of cornea when the eye was closed | 3 months post-operative | 
| Corneal sensibility | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer | Pre-operative | 
| Corneal sensibility | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer | 1 day post-operative | 
| Corneal sensibility | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer | 7 day post-operative | 
| Corneal sensibility | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer | 1 month post-operative | 
| Corneal sensibility | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer | 3 months post-operative | 
| Complication | Complication during surgery and after surgery | intraoperative | 
| Complication | Complication during surgery and after surgery | 1 day post-operative | 
| Complication | Complication during surgery and after surgery | 7 day post-operative | 
| Complication | Complication during surgery and after surgery | 1 month post-operative | 
| Complication | Complication during surgery and after surgery | 3 months post-operative | 
| Complication | Complication during surgery and after surgery | 1 year post-operative | 
| Duration | Duration of surgery | Intraoperative | 
| Cost | Cost of surgery | 1 year post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hansen Disease, Leprosy, Paralytic lagophthalmos, Surgical intervention