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临床试验/NCT02271373
NCT02271373已完成不适用

Development and Application of Appropriate Technology for Myopia Prevention and Control

Anhui Medical University0 个研究点目标入组 3,521 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,521
主要终点
Changes in uncorrected visual acuity

研究概览

简要总结

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors in northeast China.

详细描述

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors among elementary and secondary school students in northeast China. It is expected that the results will provide evidences for policy-makers and school healthcare providers for their school children myopia prevention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Grade of 1 to 5 in elementary schools and grade of 7 to 8 in secondary schools.

排除标准

  • •Visual defect or other eye diseases; wearing orthokeratology; refractive surgery history.

研究组 & 干预措施

intervention group

Experimental

The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.

干预措施: increasing time spent outdoors (Behavioral)

control group

No Intervention

The control school did not have any interventions.

结局指标

主要结局

Changes in uncorrected visual acuity

时间窗: Baseline, Month 6, Month 12

Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases).All the measurements were recorded.

次要结局

  • Questionnaire survey(Baseline)
  • Changes in ocular biometric parameters(Baseline, Month 12)

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fangbiao Tao

Dean of School of Public Health, Anhui Medical University

Anhui Medical University

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