Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Keratometry (Kmax)
研究概览
简要总结
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking
详细描述
comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patient less than 18 years old
- •keratoconus stage I-III ABCD keratoconus grading system
排除标准
- •age more than 18 years
- •previous eye surgery
- •current eye infection or pathology
研究组 & 干预措施
Standard CXL
Patients treated according to Dresden Protocol with epithelium-off CXL.
干预措施: Standard CXL (Procedure)
Accelerated CXL
Patients treated according to accelerated Protocol with epithelium-off CXL.
干预措施: Accelerated CXL (Procedure)
Transepithelial CXL
Patients treated according to transepithelial Protocol with epithelium-on CXL.
干预措施: Transepithelial CXL (Procedure)
结局指标
主要结局
Keratometry (Kmax)
时间窗: 36 months
measured in diopters (D)
Uncorrected distance visual acuity
时间窗: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
Corrected distance visual acuity
时间窗: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
Sphere
时间窗: 36 months
measured in diopters (D)
Cylinder
时间窗: 36 months
measured in diopters (D)
次要结局
未报告次要终点
研究者
Prof. Mohammed Iqbal
Professor
Sohag University