NCT01398839终止3 期
Safety Study of the VEGA UV-A System to Treat Ectasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 103
- 试验地点
- 12
- 主要终点
- Changes in Corneal Curvature
研究概览
简要总结
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
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
- None
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
- •18 Years of age or older
- •Diagnosis of Ectasia
- •Presence of central or inferior steepening
- •Topography consistent with ectasia
- •BSCVA 20/20 or worse
- •If contact lens wearer; removal of contact lenses for required period of time
- •Signed informed consent
- •Willingness and ability to comply with schedule for follow-up visits
排除标准
- •Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- •History of chemical injury or delayed epithelial healing
- •A known sensitivity to study medications
- •Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- •A condition that would interfere with or prolong epithelial healing
- •Presence or history of any other condition or finding that makes the patient unsuitable for treatment
研究组 & 干预措施
Sham Control
Sham Comparator
干预措施: Riboflavin (Drug)
CXL Treatment
Experimental
干预措施: VEGA UV-A Illumination System (Device)
CXL Treatment
Experimental
干预措施: Riboflavin (Drug)
结局指标
主要结局
Changes in Corneal Curvature
时间窗: 6 Months
次要结局
未报告次要终点
研究者
研究点 (12)
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