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

NCT07746752 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Phase

Not applicable

Started

2026-06-01

Last updated

2026-08-05

Condition(s) studied

MyopiaRefractive ErrorsHyperopia

Investigational drug(s) / intervention(s)

Wearable Device-Supported Myopia Prevention ProgramEye Health Education

Wearable Device-Supported Myopia Prevention Program: The wearable device-supported program will use smart wearable wristbands to monitor outdoor activity time and provide reminders. Students in the intervention group will be encouraged to increase outdoor activity, with targets of at least 1 hour per day on school days and at least 2 hours per day on weekends. Data recorded by the wearable device will be used to quantify daily outdoor activity and assess adherence to the intervention.

Eye Health Education: Routine school-based eye health education will include general guidance on healthy visual behaviors, including reducing prolonged near work, maintaining appropriate reading posture and lighting conditions, performing standard eye exercises, and undergoing regular eye examinations.

Study summary

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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

11 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Change in Axial Length — 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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746752 on ClinicalTrials.gov ↗ ← All trials in China