Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Cxlusa
- 入组人数
- 1,324
- 试验地点
- 11
- 主要终点
- Change in Best Spectacle Corrected Visual Acuity (BSCVA)
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.
详细描述
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Having at least one of the following conditions:
- •Keratoconus
- •Post-LASIK ectasia
- •Pellucid marginal degeneration
- •Forme fruste pellucid marginal degeneration
- •History of Radial Keratotomy with fluctuating vision.
- •Terrien's Marginal Degeneration
- •Signed written informed consent and/or assent
- •Likely to complete all study visits
- •Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, 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
Theralight crosslinking and Riboflavin
ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin
干预措施: Theralight crosslinking and Riboflavin (Other)
结局指标
主要结局
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
时间窗: 6-9 months
次要结局
- Change in Uncorrected Visual Acuity (UCVA)(6-9 months)
- Change in Corneal topography(6-9 months)
- Change in Manifest Refraction(6-9 months)
- Change in Keratometry on topography and Pentacam(6-9 months)
- Change in Wavefront Refraction and aberrations(6-9 months)