Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cxlusa
- 入组人数
- 3,493
- 试验地点
- 14
- 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
The purpose of this study is 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. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years of age or older
- •Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
- •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
- •At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)
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
Ciprofloxicin or Vigamox or other.
干预措施: Ciprofloxicin or Vigamox or other. (Drug)
Nonsteroidal (Acular, Voltaren Xibrom, etc)
干预措施: Nonsteroidal (Acular, Acuvail, 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)