Outdoor activity program with wearable support to help prevent myopia in schoolchildren with good hyperopic reserve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, school-based randomized trial assigns non-myopic children with adequate hyperopic reserve to either a wearable device–supported outdoor activity program plus routine eye health education or routine eye health education alone. Participants are stratified by grade within each school and followed for 12 months, with interim 6-month assessments. Primary outcome is change in axial length, with secondary outcomes including changes in cycloplegic refraction, myopia incidence, outdoor activity adherence, device safety, and other ocular measurements. Baseline and follow-up ophthalmic exams are conducted according to the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiangui He, PhD
• Email: xianhezi@163.com
• Phone: +86 021-62717733

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.