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

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.

Treatment received by patients was randomized by research team members. The investigator as the oculoplastic surgeon (YI) acknowledged the treatment assigned to each patient based on randomization. Outcomes were measured by other oculoplastic surgeons with equal clinical experiences.

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

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

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

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