Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Changes in questionnaire survey
研究概览
简要总结
The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.
Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.
In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● Kindergarten kids.
- •Grade of 1 to 6 in elementary schools.
- •Grade of 1 to 3 in middle schools.
- •Grade of 1 to 3 in high schools.
- •Sign the informed consent.
排除标准
- •●Visual defect or other eye diseases.
- •wearing orthokeratology; refractive surgery history.
- •Not considered suitable for inclusion in the study by the investigator.
研究组 & 干预措施
Cluster A
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years.
干预措施: Six interventions for children and adolescents (Other)
Cluster B
The study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years.
干预措施: Six interventions for children and adolescents (Other)
Cluster C
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year.
干预措施: Six interventions for children and adolescents (Other)
Cluster D
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed.
干预措施: Six interventions for children and adolescents (Other)
结局指标
主要结局
Changes in questionnaire survey
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 years
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
Changes in visual acuity in computer optometry
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 years
Optometry Automated computerized optometry is performed by an optometrist. Automatic optometry instrument using desktop computer automatic optometry, equipment requirements should conform to the "ISO10342-2010 Ophthalmic instruments: Optometry" provisions.
Changes in uncorrected vision within two years
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 years
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.
Changes in visual acuity during dilated pupil optometry
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 years
Between 5% and 10% of the participants were selected for Dilated pupil optometry.
次要结局
- Qualitative interview(Baseline, 1 year, 2 years)
- Eye protection diary(Three months.)
研究者
Fangbiao Tao
Professor and Dean, Anhui Medical University
Anhui Medical University