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RECRUITING
NCT07746752
NA

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

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-06-01

Completion Date

2027-12

Last Updated

2026-08-05

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China