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临床试验/NCT00522912
NCT00522912已完成不适用

A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,300
试验地点
1
主要终点
Trichiasis

研究概览

简要总结

Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.

In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.

The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.

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
Single (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

入选标准

  • Minor trichiasis: 1 - 5 lashes touching the eye

排除标准

  • Previous eyelid surgery.
  • Patients with evidence of corneal damage (will be offered surgery).

结局指标

主要结局

Trichiasis

时间窗: One and two years

次要结局

  • Visual acuity(One and two years)
  • Corneal opacity(One and two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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