Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- change in keratometry
研究概览
简要总结
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.
详细描述
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 keratoconus group
- •Corneal scarring
- •Pregnancy
研究组 & 干预措施
Sham treatment
Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.
干预措施: Placebo (Drug)
Treatment Arm
After randomization, the active arm will have the collagen crosslinking intervention.
干预措施: Riboflavin (Drug)
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)