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School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve

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 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.

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 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. 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. * Any other condition judged by the study doctors to make participation inappropriate.
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What it tests

  • Wearable Device-Supported Myopia Prevention Program
  • Eye Health Education
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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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