[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650492":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"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 defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol.",[13,14],"Device: Defocus Spectacle Lenses","Other: Auricular Acupressure",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Participants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Defocus Spectacle Lenses","Defocus spectacle lenses will be prescribed and fitted for eligible participants according to standardized procedures. The lenses are designed to provide refractive correction while introducing peripheral myopic defocus for myopia control. Participants with premyopia will be instructed to wear the spectacles for at least 8 hours per day, while participants with myopia will be instructed to wear them for at least 12 hours per day. Lens fitting, adaptation, follow-up, and any lens or frame adjustments will be monitored and documented during the study period. If adjustments are required due to discomfort, prescription change, poor fit, or lens\u002Fframe damage, they will be managed according to standardized procedures whenever feasible. Participants will remain in their originally assigned group for the primary intention-to-treat analysis, and lens-wear adherence and major lens adjustments may be considered in per-protocol or sensitivity analyses.",[16,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Auricular Acupressure","Auricular acupressure will be performed using auricular acupressure patches applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once per week by trained medical personnel according to a standardized protocol. Each application will remain in place for 5 days, followed by a 2-day rest period, with the treated ear alternated weekly. Participants will be instructed to press the patches three times daily, in the morning, at noon, and before bedtime, with 10 to 20 presses each time. Adherence to auricular acupressure will be assessed based on attendance at scheduled sessions, patch retention, and completion of participant pressing instructions recorded by study personnel or school health teachers. If patches fall off, loosen, or cause local discomfort, the school health teacher or study personnel will be informed and appropriate management will be provided.",[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":57,"role":34,"phone":39,"phoneExt":26,"email":40},"Jingjing Wang, PhD",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100650492","school-based-myopia-control-trial-for-children-with-premyopia-or-myopia-100650492",false,"NCT07746778","School-based Myopia Control Trial for Children With Premyopia or Myopia","A Randomized Controlled Trial of Auricular Acupressure Combined With Defocus Spectacle Lenses for Myopia Control in Children With Premyopia or Myopia","SPARK","Inclusion Criteria:\n\n* Students in grades 1 to 4 from participating primary schools.\n* Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.\n* Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.\n* Willingness to participate in baseline and follow-up assessments during the study period.\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* Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.\n* Any other condition judged by the study doctors to make participation inappropriate.","ALL","6 Years","11 Years",{"count":72,"type":73},358,"ESTIMATED","INTERVENTIONAL",[76],"NA","This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.",[79,80],"Myopia","Refractive Errors",[82,83,23,28,84],"Myopia Control","Premyopia","Axial Length","2026-07-31",{"date":87,"type":88},"2026-08-05","ACTUAL",{"date":90,"type":88},"2026-06-01",{"date":92,"type":73},"2027-12",{"name":5,"class":6},1]