NCT03922542已完成2 期
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 508
- 试验地点
- 3
- 主要终点
- Change in maximum keratometry
研究概览
简要总结
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented keratoconus or ectasia after refractive surgery
排除标准
- •Insufficient corneal thickness
- •Ocular condition that may predispose the eye to complications
- •History of chemical injury or delayed epithelial healing
- •Condition that would interfere with or prolong epithelial healing
- •Known sensitivity to treatment medications
- •Pregnancy
研究组 & 干预措施
Accelerated
Active Comparator
Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
干预措施: riboflavin 0.1% (Combination Product)
Standard
Active Comparator
Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
干预措施: Riboflavin 0.1% (Combination Product)
结局指标
主要结局
Change in maximum keratometry
时间窗: 6 months
assessed by corneal tomography
次要结局
- Change in uncorrected distance visual acuity(6 months)
- Change in corrected distance visual acuity(6 months)
研究者
研究点 (3)
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