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School-based Myopia Control Trial for Children With Premyopia or Myopia

RecruitingNAAges 6 Years - 11 YearsAllShanghai Eye Disease Prevention and Treatment Cenโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Defocus Spectacle Lenses
  • Auricular Acupressure
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Where

1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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