An interventional study of Wearable Device-Supported Myopia Prevention Program and Eye Health Education in Myopia, Refractive Errors and Hyperopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Recruiting at 1 site in China. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 104 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group will receive a wearable device-supported outdoor activity program in addition to routine school-based eye health education during the 12-month study period.
Behavioral: Wearable Device-Supported Myopia Prevention Program · Behavioral: Eye Health Education
Participants in the control group will receive routine school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive structured outdoor activity targets, wearable device-supported outdoor activity monitoring, or reminders.
Behavioral: Eye Health Education
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.
Change 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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Shanghai Eye Disease Prevention and Treatment Center