NCT01809977已完成2 期
Study of Surgical Methods for Keratoconus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
The purpose of this study is to determine which surgical method makes less corneal haze
详细描述
Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 16-40 years
- •axial topography consistent with keratoconus
- •minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months
排除标准
- •history of ocular herpes or non-healing corneal ulcers
- •subjects with current ocular infection
- •severe preoperative corneal haze or scar
- •severe ocular surface disease
- •autoimmune diseases
- •pregnant women
结局指标
主要结局
Best corrected visual acuity
时间窗: at six months after surgery
determining corrected visual acuity in partial removal versus total removal of the corneal epithelium
次要结局
- Corneal optical density(at six months after surgery)
研究者
Hamidreza Shemshaki
MD, Research Assistant
Isfahan University of Medical Sciences
研究点 (1)
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