A Randomized Controlled Trial of Auricular Acupressure Combined With Defocus Spectacle Lenses for Myopia Control in Children With Premyopia or Myopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Change in axial length from baseline to 12 months
研究概览
简要总结
This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.
详细描述
This prospective, school-based randomized controlled trial will be conducted among primary school students with premyopia or myopia. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the study criteria for premyopia or myopia based on cycloplegic spherical equivalent refraction and whose parents or legal guardians provide written informed consent.
Premyopia is defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D. Myopia is defined as cycloplegic spherical equivalent refraction in the worse eye less than or equal to -0.50 D.
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 defocus spectacle lenses combined with auricular acupressure according to the study protocol. The control group will receive defocus spectacle lenses alone according to the study protocol. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. Auricular acupressure will be delivered by trained medical personnel using auricular acupressure patches applied to selected auricular acupoints according to the standardized study protocol.
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, adherence to the assigned intervention, 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
- 否
入选标准
- •Students in grades 1 to 4 from participating primary schools.
- •Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
- •Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
- •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 defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol.
干预措施: Defocus Spectacle Lenses (Device)
Intervention Group
Participants in the intervention group will receive defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol.
干预措施: Auricular Acupressure (Other)
Control Group
Participants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure.
干预措施: Defocus Spectacle Lenses (Device)
结局指标
主要结局
Change in axial length from baseline to 12 months
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 from baseline to 12 months(Baseline to 12 months)
- Adherence to the assigned intervention(During the 12-month follow-up period)
- Safety outcomes and adverse events(During the 12-month follow-up period)