NCT07080983已完成不适用
Efficacy of Corneal Cross-Linking (CXL) in the Treatment of Pediatric Keratoconus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- keratometry (Kmax)
研究概览
简要总结
This prospective interventional study investigates the efficacy of corneal cross-linking (CXL) in managing progressive keratoconus in pediatric patients. The procedure involved standard epithelium-off CXL, and patients were followed to assess outcomes such as visual acuity, keratometric stability, and corneal thickness.
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
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 18 years
- •Clinical and topographic diagnosis of keratoconus based on the Belin/Ambrosio Enhanced Ectasia Display
- •Evidence of progression within the past 6-12 months (e.g., an increase in maximum keratometry (Kmax) by ≥1.0 diopter, a decrease in minimal corneal thickness by ≥10 µm, or deterioration in visual acuity not attributable to other causes
排除标准
- •Corneal scarring or opacities.
- •Active ocular infection or inflammation.
- •Prior ocular surgery or trauma.
- •Autoimmune or connective tissue disorders.
结局指标
主要结局
keratometry (Kmax)
时间窗: After 12 months
Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.
BCVA
时间窗: After 12 months
Measurment of the visual acuity
次要结局
未报告次要终点
研究者
Ehab Tharwat
Princibal Investigator
Al-Azhar University
研究点 (3)
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