NCT00925327Unknown2 期
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
Peschke Meditrade, GmbH2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年6月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in keratometry
研究概览
简要总结
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.
详细描述
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 18 years
- •Having a diagnosis of progressive keratoconus
- •Signed written informed consent
- •Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
- •Willingness and ability to comply with schedule for follow-up visits
排除标准
- •Corneal pachymetry at the screening exam that is <400 microns at the thinnest point
- •Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- •A history of delayed epithelial healing in the eye(s) to be treated
- •Pregnancy or lactation during the course of the study
- •A known sensitivity to study medications
结局指标
主要结局
Change in keratometry
时间窗: 3 Months
次要结局
- Change in manifest refraction spherical equivalent(3 Month)
研究者
研究点 (2)
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