NCT01190306终止3 期
Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus
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
- 127
- 试验地点
- 9
- 主要终点
- Change in Corneal Curvature.
研究概览
简要总结
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.
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
- •12 years of age or older
- •Having a diagnosis of keratoconus
- •Presence of central or inferior steepening
- •Topography consistent with keratoconus
- •Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
- •Contact lens wearers only:Removal of contact lenses for the required period of time
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow-up visits
排除标准
- •For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
- •Corneal pachymetry ≤ 400 microns
- •Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
- •A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- •Pregnancy (including plan to become pregnant) or lactation during the course of the study
- •A known sensitivity to study medications
- •Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
- •A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- •Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
研究组 & 干预措施
CXL Treatment
Experimental
Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
干预措施: The VEGA UV-A Illumination System (Device)
CXL Treatment
Experimental
Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
干预措施: Riboflavin (Drug)
Sham Control
Active Comparator
Eyes in the control group will be treated with riboflavin only.
干预措施: Riboflavin (Drug)
结局指标
主要结局
Change in Corneal Curvature.
时间窗: 6 Months
次要结局
未报告次要终点
研究者
研究点 (9)
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