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临床试验/NCT05612568
NCT05612568进行中(未招募)不适用

Five Years of Eye Screening for Amblyopia Risk Factors in Children Aged <3 Years in Flanders: Epidemiological Retrospective Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 250,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250,000
试验地点
1
主要终点
Refractive error per eye

研究概览

简要总结

Researchers will investigate the distribution and evolution of amblyopia risk factors and other refractive errors in children younger than 3 years of age. The significance and magnitude of current global evolutions in ARF and refractive errors will be verified to update current guidelines and practices. Better insight in associated factors of amblyopia risk factors will contribute to current understanding of amblyopia.

详细描述

The eye screening program of the Flemish governmental agency 'Kind en Gezin' is a well-implemented screening program for detection of ARF in children under the age of 3 years. This screening covers almost 85% of all children born in the Flemish community. Valuable information about distribution and determinants of refractive errors and ARF are collected at 'Kind en Gezin', but remain unstudied until today.

The aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in Flanders. One supposes that identification of patterns in this distribution, and identification of determinants that influence ARF, will lead to improved knowledge about amblyopia (risk factors) and on their turn help optimize the ARF screening program. Evaluation of the distribution and evolution of refractive errors over time, and comparison with global results, will also give researchers insight in the significance of the myopia epidemic in Flanders.

研究设计

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

入排标准

年龄范围
13 Months 至 31 Months(Child)
性别
All
接受健康志愿者

入选标准

  • We include all children with a PlusOptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months. Children who were screened twice, can be included twice with both screening results.

排除标准

  • 未提供

结局指标

主要结局

Refractive error per eye

时间窗: Day 1

Sphere, cylinder, spherical equivalent

Difference in refractive error between both eyes

时间窗: Day 1

Sphere OD-OS, cylinder OD-OS, spherical equivalent OD-OS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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