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临床试验/NCT05691335
NCT05691335已完成不适用

Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Sohag University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Uncorrected distance visual acuity

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

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

结局指标

主要结局

Uncorrected distance visual acuity

时间窗: 36 months

measured in logarithm of minimal angle of resolution (logMAR)

Keratometry (Kmax)

时间窗: 36 months

measured in diopters (D)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Mohammed Iqbal

Professor

Sohag University

研究点 (2)

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