NCT02980445Unknown不适用
Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 7,200
- 主要终点
- Cycloplegic refractive power（auto-refractor instrument）
研究概览
简要总结
The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.
详细描述
- To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
- To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
- To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at baseline be enrolled in grade 1 and 2 of primary schools;
- •have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
- •Children verbally consent when registration for examination
排除标准
- •Any systemic or ocular pathology that may affect the refractive error status of the eye;
- •Strabismus and amblyopia;
- •Intellectual disability;
- •Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
- •Not suitable for inclusion in the study as deemed by the investigator.
结局指标
主要结局
Cycloplegic refractive power（auto-refractor instrument）
时间窗: 1 year
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
次要结局
- Axial length(IOL Master instrument)(6 months)
研究者
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