A Randomized Controlled Trial of a School-based Wearable Device-Supported Outdoor Activity Program for Myopia Prevention in Children With Adequate Hyperopic Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
This is a prospective, school-based randomized controlled trial designed to evaluate a wearable device-supported outdoor activity program for myopia prevention in primary school students with adequate hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either a wearable device-supported outdoor activity program plus routine school-based eye health education or routine school-based eye health education alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.
详细描述
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with adequate hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the age-specific criteria for adequate hyperopic reserve based on cycloplegic spherical equivalent refraction in the worse eye and whose parents or legal guardians provide written informed consent.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive routine school-based eye health education and wearable device-supported monitoring and reminders for outdoor activity. The control group will receive routine school-based eye health education and maintain usual daily activities without wearable device-supported outdoor activity monitoring or reminders.
Baseline and follow-up assessments will include ophthalmic examinations according to the study protocol. An interim follow-up assessment will also be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, the incidence of myopia during follow-up, achievement of outdoor activity targets, adherence to wearable device use, and safety outcomes and adverse events.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students in grades 1 to 4 from participating schools.
- •Non-myopic children with adequate hyperopic reserve at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye within the following age-specific reference ranges: +1.72 D to +2.45 D at age 6 years; +1.48 D to +2.00 D at age 7 years; +1.19 D to +1.79 D at age 8 years; +1.11 D to +1.38 D at age 9 years; +0.92 D to +1.16 D at age 10 years; and +0.83 D to +1.07 D at age 11 years.
- •Written informed consent provided by a parent or legal guardian, with assent obtained from the child when appropriate.
排除标准
- •Strabismus, amblyopia, or other ocular abnormalities.
- •Systemic disease or other medical conditions that may affect study participation.
- •Has received any myopia prevention intervention in the past 3 months.
- •Any other condition judged by the study doctors to make participation inappropriate.
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive a wearable device-supported outdoor activity program in addition to routine school-based eye health education during the 12-month study period.
干预措施: Wearable Device-Supported Myopia Prevention Program (Behavioral)
Intervention Group
Participants in the intervention group will receive a wearable device-supported outdoor activity program in addition to routine school-based eye health education during the 12-month study period.
干预措施: Eye Health Education (Behavioral)
Control Group
Participants in the control group will receive routine school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive structured outdoor activity targets, wearable device-supported outdoor activity monitoring, or reminders.
干预措施: Eye Health Education (Behavioral)
结局指标
主要结局
Change in Axial Length
时间窗: Baseline to 12 months
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
次要结局
- Change in Cycloplegic Spherical Equivalent Refraction(Baseline to 12 months)
- Incidence of Myopia During Follow-up(During the 12-month follow-up period)
- Adherence to Wearable Device Use(During the 12-month follow-up period)
- Safety Outcomes and Adverse Events(During the 12-month follow-up period)