NCT01398852终止3 期
Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Changes in Corneal Curvature
研究概览
简要总结
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •12 years of age or older
- •Diagnosis of Keratoconus or Ectasia
- •Central or Inferior steepening on the Pentacam map
- •Topography consistent with Keratoconus or Ectasia
- •BSCVA 20/20 or worse
- •Removal of contact lenses for required period of time
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow up visits
- •Exclusion Criteria
- •For Keratoconus, a history of previous corneal surgery
- •Corneal pachymentry equal to or greater and 400
- •Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
- •A history of chemical injury or delayed healing
- •Pregnancy
- •A known sensitivity to the study medications
- •Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
- •Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
排除标准
- 未提供
研究组 & 干预措施
CXL Treatment
Experimental
All eyes to be treated with riboflavin and UV light
干预措施: Riboflavin (Drug)
CXL Treatment
Experimental
All eyes to be treated with riboflavin and UV light
干预措施: VEGA UV-A Illumination System (Device)
结局指标
主要结局
Changes in Corneal Curvature
时间窗: 24 MO
次要结局
未报告次要终点
研究者
研究点 (13)
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