A Randomized Controlled Trial of School-based Auricular Acupressure for Myopia Prevention in Non-myopic Children With Insufficient Hyperopic Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 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 auricular acupressure for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. 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 insufficient hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the eligibility criteria for insufficient hyperopic reserve and whose parents or legal guardians provide written informed consent.
Insufficient hyperopic reserve is defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D but lower than the age-specific reference value for hyperopic reserve.
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 auricular acupressure administered according to the study protocol in addition to standard school-based eye health education. The control group will receive standard school-based eye health education only and will not receive auricular acupressure or other additional study-related myopia prevention intervention.
Comprehensive ophthalmic examinations will be conducted at baseline and 12 months according to the study protocol. An interim follow-up visit will 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, adherence to auricular acupressure, 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 primary schools.
- •Non-myopic children with insufficient hyperopic reserve, defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D and below the following age-specific upper limits: +1.72 D at age 6 years; +1.48 D at age 7 years; +1.19 D at age 8 years; +1.11 D at age 9 years; +0.92 D at age 10 years; and +0.83 D at age 11 years.
- •Written informed consent provided by a parent or legal guardian, with willingness to participate in baseline and follow-up assessments during the study period.
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.
- •Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.
- •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 auricular acupressure for myopia prevention during the 12-month study period. The intervention will be delivered by trained medical personnel according to a standardized protocol.
干预措施: Auricular Acupressure (Other)
Intervention Group
Participants in the intervention group will receive auricular acupressure for myopia prevention during the 12-month study period. The intervention will be delivered by trained medical personnel according to a standardized protocol.
干预措施: Eye Health Education (Behavioral)
Control Group
Participants in the control group will receive standard school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive auricular acupressure or other additional study-related myopia prevention intervention.
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
Defined as the difference in axial length between the 12-month follow-up visit and 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 auricular acupressure(During the 12-month follow-up period)
- Safety Outcomes and Adverse Events(During the 12-month follow-up period)