Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Duration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patient with acute leprosy reaction (<6 months) and in steroid medication
- •patient with eyelid laxity >8 mm
结局指标
主要结局
Duration
时间窗: Intraoperative
Duration of surgery
Cost
时间窗: 1 year post-operative
Cost of surgery
Lagophthalmos distance without pressure
时间窗: 1 year post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance with gentle pressure
时间窗: 1 year post-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)
时间窗: 1 year post-operative
Questionnaire assessing subjective dry eyes symptoms
TBUT (Tear Break-Up Time)
时间窗: 3 months post-operative
Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp
Schirmer test without anesthesia
时间窗: 1 year post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test with anesthesia
时间窗: 1 year post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Corneal exposure
时间窗: 3 months post-operative
Exposed distance of cornea when the eye was closed
Epitheliopathy
时间窗: 3 months post-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Corneal sensibility
时间窗: 3 months post-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Complication
时间窗: 1 year post-operative
Complication during surgery and after surgery
次要结局
未报告次要终点
研究者
Yunia Irawati
Principal Investigator
Gadjah Mada University