RecruitingNot ApplicableNCT07746752

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

A Randomized Controlled Trial of a School-based Wearable Device-Supported Outdoor Activity Program for Myopia Prevention in Children With Adequate Hyperopic Reserve

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Enrollment

104 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Myopia Refractive errors Hyperopia

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

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Eye Health Education and a behavioral approach called Wearable Device-Supported Myopia Prevention Program for people with hyperopia, myopia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALWearable 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.

BEHAVIORALEye 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.