NCT01024322终止不适用
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cxlusa
- 入组人数
- 1,189
- 试验地点
- 2
- 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.
- •Terrien's Marginal Degeneration
- •Ability to provide written informed consent
- •Likely to complete all study visits
- •Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
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
研究组 & 干预措施
Ciprofloxicine or Vigamox or other.
干预措施: Ciprofloxicine or Vigamox or other. (Drug)
Nonsteroidal (Acular, Voltaren Xibrom, etc)
干预措施: Nonsteroidal (Acular, Voltaren Xibrom, etc) (Drug)
Steroid (FML, Pred Forte, Flarex, etc.)
干预措施: Steroid (FML, Pred Forte, Flarex, etc.) (Drug)
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 (2)
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