Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- corneal neovascularization as a proportion of the total corneal area
研究概览
简要总结
The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •With active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids.
- •Signed written informed consent.
排除标准
- •Known sensitivity to treatment medications
- •Current condition that in the investigator's opinion could compromise safety or data integrity.
- •Pregnancy (including plan to become pregnant) or lactation during the course of the study
研究组 & 干预措施
30 minute photoactivation
photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes
干预措施: 30 minute photoactivation of riboflavin 0.1% (Combination Product)
10 minute photoactivation
photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes
干预措施: 10 minute photoactivation of riboflavin 0.1% (Combination Product)
结局指标
主要结局
corneal neovascularization as a proportion of the total corneal area
时间窗: 6 months
the cornea will be photographed and morphometric image analysis software will be used to measure corneal neovascularization as a proportion of the total corneal area. The proportion measured at baseline will be compared with the proportion measured at 6 months after treatment.
次要结局
未报告次要终点