Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Eyes classified as either normal, atypical normal,
- •Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
- •A history of chemical injury or delayed epithelial healing in the eye to be treated.
- •A known sensitivity to study medications
- •Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
- •Inability to cooperate with diagnostic tests.
- •Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- •Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- •Patients who are unable to remain comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.
研究组 & 干预措施
Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
干预措施: UV Light - Continuous Beam (Device)
Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
干预措施: Epithelium-On Riboflavin (Drug)
Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
干预措施: UV Light - Continuous Beam (Device)
Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
干预措施: Epithelium-Off Riboflavin (Drug)
Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
干预措施: Epithelium-On Riboflavin (Drug)
Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
干预措施: UV Pulsed Beam (Device)
Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
干预措施: Epithelium-Off Riboflavin (Drug)
Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
干预措施: UV Pulsed Beam (Device)
结局指标
主要结局
Visual Acuity
时间窗: 2 years
Uncorrected visual acuity
次要结局
未报告次要终点