Epithelium-On Corneal Collagen Crosslinking for Keratoconus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum keratometric change
研究概览
简要总结
Epithelium-On Corneal Crosslinking for Keratoconus.
详细描述
Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination.
The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).
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
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits
排除标准
- •Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry <350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
- •Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.
研究组 & 干预措施
Treatment
Treatment as per protocol, there is no placebo arm.
干预措施: Riboflavin 5'-Phosphate (Drug)
结局指标
主要结局
Maximum keratometric change
时间窗: 12 months
Change from baseline keratometric maximum over time.
次要结局
- Visual acuity change(12 months)