Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 10
- 主要终点
- Mean Change From Baseline in Maximum Keratometry (Kmax)
研究概览
简要总结
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
详细描述
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
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
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus
- •Documented progression over previous 24 months
- •Decreased BSCVA
- •Must complete all study visits
排除标准
- •Prior corneal surgery or Intacs
- •History of delayed wound healing
研究组 & 干预措施
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
干预措施: riboflavin ophthalmic solution (Drug)
Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
干预措施: UVA Irradiation (Device)
Control Group
riboflavin ophthalmic solution without UVA irradiation.
干预措施: riboflavin ophthalmic solution (Drug)
结局指标
主要结局
Mean Change From Baseline in Maximum Keratometry (Kmax)
时间窗: baseline,12 months
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
次要结局
未报告次要终点