NCT02009709Unknown1 期
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia
Robert Mack, M.D.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease in maximum corneal curvature
研究概览
简要总结
The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.
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
- 18 Years 至 80 Years（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
9 mW/cm2
Active Comparator
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
干预措施: Riboflavin 0.1% ophthalmic solution (Drug)
9 mW/cm2
Active Comparator
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
干预措施: CCL-VARIO UV lamp (Device)
18 mW/cm2
Active Comparator
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
干预措施: Riboflavin 0.1% ophthalmic solution (Drug)
18 mW/cm2
Active Comparator
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
干预措施: CCL-VARIO at 18 mW/cm2 (Device)
结局指标
主要结局
Decrease in maximum corneal curvature
时间窗: 3 and 6 months post-procedure
次要结局
未报告次要终点
研究者
Robert Mack, M.D.
Sponsor-Investigator
Mack Eye Center
研究点 (1)
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