A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Recurrent trichiasis
研究概览
简要总结
Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis. Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is to compare the outcome of surgery (at one and two years) for trichiasis using two currently used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the researchers, hypothesise that the supportive presence of the absorbable suture for a longer period produces more stable wound healing, leading to a better outcome.
详细描述
Primary outcome measure:
Recurrent trichiasis, defined as one or more eyelashes touching the globe or evidence of epilation (lash stubs) on examination, or a history of repeat trichiasis surgery since the baseline surgery, at one year.
Justification of primary outcome:
The aim of surgery is a permanent solution for trichiasis. If a patient has eyelashes touching the eyeball or there is clinical evidence that they are epilating to prevent this or they have required repeat trichiasis surgery, surgery can be deemed a failure.
Analysis of primary outcome measure
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, Investigator, Outcomes Assessor)
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
- •Major trichiasis: more than 5 lashes touching the eye
排除标准
- •Previous eyelid surgery
结局指标
主要结局
Recurrent trichiasis
时间窗: One and two years
Recurrent trichiasis, defined as one or more eyelashes touching the globe or evidence of epilation (lash stubs) on examination, or a history of repeat trichiasis surgery since the baseline surgery, at one year.
次要结局
- Entropion(One and two years)
- Corneal opacity(One and two years)
- Visual Acuity Change(One and Two years)
- Conjunctivilisation of the lid margin grade(One and two years)
- Repeat Trichiasis Surgery(At any time during two years followup.)