The K-Map Study, Global Prevalence of KC
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
- 是
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
Farhad Hafezi
MDPhD
University Hospital, Geneva
