NCT07841470招募中2 期
Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia: Randomized Comparison of Pulsed vs. Non-pulsed Treatment
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in maximum keratometry
研究概览
简要总结
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.
详细描述
Subjects diagnosed with keratoconus or corneal ectasia are randomized to one of two corneal crosslinking light durations.
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 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus or corneal ectasia
- •Provision of written informed consent
排除标准
- •Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- •Clinically significant corneal scarring in the proposed treatment zone
- •History of chemical injury or delayed epithelial healing in the study eye
- •Known sensitivity to study medication
- •A current condition, including clinically significant dry eyes or use of medications know to induce dry eye symptoms, that, in the treating physician's opinion, would interfere with or prolong epithelial healing
- •Pregnancy (including plan to become pregnant) or lactation during the course of the study
研究组 & 干预措施
Non-pulsed
Active Comparator
Treatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes
干预措施: Riboflavin 0.1% ophthalmic solution and non-pulsed light (Combination Product)
Pulsed
Active Comparator
Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes
干预措施: Riboflavin 0.1% ophthalmic solution and pulsed light (Combination Product)
结局指标
主要结局
Change in maximum keratometry
时间窗: 6 months
assessed with corneal tomography
次要结局
- change in corrected distance visual acuity(6 months)
- change in uncorrected distance visual acuity(6 months)
研究者
研究点 (1)
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