跳至主要内容
临床试验/NCT03115710
NCT03115710招募中不适用

The K-Map Study, Global Prevalence of KC

University Hospital, Geneva4 个研究点 分布在 4 个国家目标入组 20,000 人开始时间: 2015年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20,000
试验地点
4
主要终点
Prevalence of keratoconus

研究概览

简要总结

Keratoconus is a ocular disease classified under ectatic diseases which often results in bilateral and asymmetrical corneal distortion. It usually affects patients at young age and can cause severe visual loss.

The overall goal of this study is to assess the prevalence of keratoconus (KC) in children and adolescents in various regions of the world based on modern tomographic imaging methods, and to verify whether the occurrence rates reported from literature should be corrected. Our hypothesis is that the prevalence of the disease is much higher than that traditionally reported.

At each site, corneal tomography examinations (Pentacam) will be performed bilaterally in children and adolescents, who are not ill or with any ophthalmological symptom. The population to be studied will be composed of children and adolescents on medical visits for non-ophthalmologic reasons, aged between 6 and 20 years. Multiple cities, from different continents (North America, South America, Asia and Europe) will participate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 23 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, 6-23 years of age.
  • Subjects seen for a non-ophthalmic appointment
  • Provide signed and dated patient consent form (signed by parents / legal guardians).
  • Willing to comply with all study procedures and be available for the duration of the study

排除标准

  • Patients with a preexisting ocular disease / condition
  • Pregnancy or breastfeeding

结局指标

主要结局

Prevalence of keratoconus

时间窗: 15 minutes

Number of keratoconus cases detected

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

Farhad Hafezi

MDPhD

University Hospital, Geneva

研究点 (4)

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