Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,721
- 试验地点
- 83
- 主要终点
- Mean change in maximum corneal curvature (Kmax) from baseline
研究概览
简要总结
The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
VibeX Treatment Group B
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
干预措施: KXL System (30 mW/cm2) (Device)
VibeX Treatment Group A
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
干预措施: KXL System (15 mW/cm2) (Device)
VibeX Treatment Group A
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
干预措施: riboflavin ophthalmic solution (Drug)
VibeX Treatment Group B
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
干预措施: riboflavin ophthalmic solution (Drug)
VibeX Treatment Group C
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
干预措施: KXL System (45 mW/cm2) (Device)
VibeX Treatment Group C
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
干预措施: riboflavin ophthalmic solution (Drug)
结局指标
主要结局
Mean change in maximum corneal curvature (Kmax) from baseline
时间窗: Month 6 or 12
次要结局
- Comparison of treatment groups within each treatment indication(Month 6 and 12)