School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Recruiting now · Not applicable
Conditions studied: Myopia, Refractive Errors, Hyperopia
In brief
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.
Key facts
- Study ID
- NCT07746752
- Run by
- Shanghai Eye Disease Prevention and Treatment Center
- People needed
- 104
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Shanghai Eye Disease Prevention and Treatment Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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