[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650451":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Shanghai Eye Disease Prevention and Treatment Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","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.",[13,14],"Behavioral: Wearable Device-Supported Myopia Prevention Program","Behavioral: Eye Health Education",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","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.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[16,9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiangui He, PhD","CONTACT","+86 021-62717733","xianhezi@163.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Jingjing Wang, PhD","13011220912","13011220912@163.com",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,56],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100650451","school-based-myopia-prevention-trial-for-children-with-adequate-hyperopic-reserve-100650451",false,"NCT07746752","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","SPARK","Inclusion Criteria:\n\n* Students in grades 1 to 4 from participating schools.\n* Non-myopic children with adequate hyperopic reserve at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye within the following age-specific reference ranges: +1.72 D to +2.45 D at age 6 years; +1.48 D to +2.00 D at age 7 years; +1.19 D to +1.79 D at age 8 years; +1.11 D to +1.38 D at age 9 years; +0.92 D to +1.16 D at age 10 years; and +0.83 D to +1.07 D at age 11 years.\n* Written informed consent provided by a parent or legal guardian, with assent obtained from the child when appropriate.\n\nExclusion Criteria:\n\n* Strabismus, amblyopia, or other ocular abnormalities.\n* Systemic disease or other medical conditions that may affect study participation.\n* Has received any myopia prevention intervention in the past 3 months.\n* Any other condition judged by the study doctors to make participation inappropriate.",true,"ALL","6 Years","11 Years",{"count":72,"type":73},104,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79,80,81],"Myopia","Refractive Errors","Hyperopia",[83,84,85,86],"Myopia Prevention","Adequate Hyperopic Reserve","School-based Myopia Prevention","Outdoor Activity","2026-07-31",{"date":89,"type":90},"2026-08-05","ACTUAL",{"date":92,"type":90},"2026-06-01",{"date":94,"type":73},"2027-12",{"name":5,"class":6},1]