NCT01097447终止不适用
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cxlusa
- 入组人数
- 2,619
- 试验地点
- 5
- 主要终点
- Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
研究概览
简要总结
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 years of age or older
- •Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
- •Diagnosis of FFKC
- •History of Radial Keratotomy with fluctuating vision.
- •Ability to provide written informed consent
- •Likely to complete all study visits
- •Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam
排除标准
- •Severe corneal scarring that markedly affects vision
- •Contraindications to any study medications or their components
- •Pregnancy or breast feeding
- •Active Herpes Corneal Disease
结局指标
主要结局
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
时间窗: 1 year
次要结局
- increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin(1 year)
研究者
研究点 (5)
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