Leprosy--Patients, Paralytic Lagophthalmos
Conditions
Keywords
Hansen Disease, Leprosy, Paralytic lagophthalmos, Surgical intervention
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.
Interventions
PROCEDUREModified Tarsorrhaphy
A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
PROCEDUREGold Weight Implant
Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess
Sponsors
Yunia Irawati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lagophthalmos distance without pressure | Pre-operative | Eyelid margin distance in central, nasal, and temporal area measured in millimeters |
| Lagophthalmos distance with gentle pressure | Pre-operative | Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid |
| OSDI (Ocular Surface Disease Index) | Pre-operative | Questionnaire assessing subjective dry eyes symptoms |
| TBUT (Tear Break-Up Time) | Pre-operative | Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp |
| Schirmer test without anesthesia | Pre-operative | Tear film excretion examined using Whatman filter paper without anesthesia |
| Schirmer test with anesthesia | Pre-operative | Tear film excretion examined using Whatman filter paper with anesthesia prior to examination |
| Epitheliopathy | Pre-operative | Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp |
| Corneal exposure | Pre-operative | Exposed distance of cornea when the eye was closed |
| Corneal sensibility | Pre-operative | Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer |
| Complication | intraoperative | Complication during surgery and after surgery |
| Duration | Intraoperative | Duration of surgery |
| Cost | 1 year post-operative | Cost of surgery |
Countries
Indonesia
Outcome results
None listed