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.
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with adequate hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the age-specific criteria for adequate hyperopic reserve based on cycloplegic spherical equivalent refraction in the worse eye and whose parents or legal guardians provide written informed consent. Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive routine school-based eye health education and wearable device-supported monitoring and reminders for outdoor activity. The control group will receive routine school-based eye health education and maintain usual daily activities without wearable device-supported outdoor activity monitoring or reminders. Baseline and follow-up assessments will include ophthalmic examinations according to the study protocol. An interim follow-up assessment will also be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, the incidence of myopia during follow-up, achievement of outdoor activity targets, adherence to wearable device use, and safety outcomes and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
104
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.
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.
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China
RECRUITINGChange in Axial Length
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
Time frame: Baseline to 12 months
Change in Cycloplegic Spherical Equivalent Refraction
Change in cycloplegic spherical equivalent refraction is defined as the difference between the 12-month value and the baseline value.
Time frame: Baseline to 12 months
Incidence of Myopia During Follow-up
Defined as the proportion of participants who develop myopia during follow-up, with myopia defined as uncorrected visual acuity less than 5.0 in either eye and non-cycloplegic spherical equivalent refraction less than -0.50 D in either eye.
Time frame: During the 12-month follow-up period
Adherence to Wearable Device Use
Defined as adherence to wearing the study wearable device during the intervention period, as assessed using data recorded by the wearable device.
Time frame: During the 12-month follow-up period
Safety Outcomes and Adverse Events
Defined as the occurrence of any adverse events related to wearable device use or increased outdoor activity, including skin irritation, device-related discomfort, eye discomfort related to sunlight exposure, or outdoor activity-related injuries.
Time frame: During the 12-month follow-up period
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