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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess
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
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: Pre-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: 1 day post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: 7 day post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: 1 month post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: 3 months post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: Pre-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: 1 day post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: 7 day post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: 1 month post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: 3 month post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Time frame: 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
Time frame: Pre-operative
TBUT (Tear Break-Up Time)
Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: Pre-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: 1 day post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: 7 day post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: 1 month post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: 3 months post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Time frame: 1 year post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: Pre-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: 1 day post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: 7 day post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: 1 month post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: 3 months post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Time frame: 1 year post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Time frame: Pre-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Time frame: 1 day post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Time frame: 7 day post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Time frame: 1 month post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Time frame: 3 months post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Time frame: Pre-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Time frame: 1 day post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Time frame: 7 day post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Time frame: 1 month post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Time frame: 3 months post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Time frame: Pre-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Time frame: 1 day post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Time frame: 7 day post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Time frame: 1 month post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Time frame: 3 months post-operative
Complication
Complication during surgery and after surgery
Time frame: intraoperative
Complication
Complication during surgery and after surgery
Time frame: 1 day post-operative
Complication
Complication during surgery and after surgery
Time frame: 7 day post-operative
Complication
Complication during surgery and after surgery
Time frame: 1 month post-operative
Complication
Complication during surgery and after surgery
Time frame: 3 months post-operative
Complication
Complication during surgery and after surgery
Time frame: 1 year post-operative
Duration
Duration of surgery
Time frame: Intraoperative
Cost
Cost of surgery
Time frame: 1 year post-operative
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