Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post treatment topographic analysis of Crosslinked patients
研究概览
简要总结
This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.
详细描述
Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.
排除标准
- •Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.
结局指标
主要结局
Post treatment topographic analysis of Crosslinked patients
时间窗: One Year
Pre-treatment videokeratography will be compared to post treatment keratography at certain intervals up to one year. Overall flattening of corneal curvature will be a primary study item.
次要结局
- Post Treatment Best Corrected Visual Acuity(One Year)
研究者
Brian J. McNeel
O.D., F.A.A.O.
McNeel Eye Center