Randomized Trial of a Wearable Device Outdoor Activity Program to Prevent Myopia in Primary School Children with Adequate Hyperopic Reserve

What this Trial Is About

Researchers are studying a wearable device-supported outdoor activity program aimed at preventing myopia in primary school children who have sufficient hyperopic reserve. This school-based, randomized controlled trial includes students in grades 1 to 4 who do not have myopia but meet specific age-related criteria for hyperopic reserve. The study compares the effects of this outdoor activity program combined with routine eye health education against routine eye health education alone over a 12-month period. Participants in the intervention group receive smart wearable wristbands that monitor their outdoor activity and provide reminders to encourage at least 1 hour of outdoor time on school days and 2 hours on weekends. Both groups continue to receive routine school-based eye health education focusing on healthy visual habits. The control group maintains their usual daily activities without wearable monitoring or reminders. Assessments occur at baseline, 6 months, and 12 months, including eye exams measuring axial length and refractive error. Throughout the study, participants undergo ophthalmic examinations to measure changes in axial length and cycloplegic spherical equivalent refraction, as well as assessments of incident myopia and adherence to the wearable device use. Safety outcomes and any adverse events are monitored during the 12-month follow-up. The primary outcome is the change in axial length from baseline to 12 months, with secondary outcomes including refractive error changes, myopia incidence, and intervention adherence. The total participation duration is 12 months.

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