Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in keratometry
研究概览
简要总结
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.
详细描述
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.
Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus with documented progression over the previous 12 months.
- •Diagnosis of corneal ectasia
- •Must be able to complete all study visits
排除标准
- •Prior corneal surgery in the keratoconus group
- •Corneal scarring
研究组 & 干预措施
Treatment
Corneal collagen cross-linking
干预措施: Corneal collagen (Procedure)
Control
Sham Treatment
干预措施: Sham comparator (Procedure)
结局指标
主要结局
Change in keratometry
时间窗: 3 Months
次要结局
- Best spectacle-corrected visual acuity(3 Months)