[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651827":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":86,"whyStopped":25,"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","Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches",[13,14],"Device: Artificial Intelligence Assisted DIMS based Spectacle Lens","Device: Smartwatches",{"label":16,"type":6,"description":17,"interventionNames":18},"Control group","Wear smartwatches",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Artificial Intelligence Assisted DIMS based Spectacle Lens","The AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Smartwatches","Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.",[16,9],[31],{"name":32,"affiliation":5,"role":33},"He, Prof","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Xiangui He, Prof","CONTACT","+86 15000755422","xianhezi@163.com",[41],{"facility":5,"status":25,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shanghai","Shanghai Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":54,"role":37,"phone":55,"phoneExt":25,"email":56},"Tianyu Cheng, Dr","+86 18817552005","s70444@126.com",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60],{"name":61,"class":62},"HOYA Lens Thailand LTD.","INDUSTRY","100651827","myopia-prevention-in-young-premyopic-children-using-defocus-incorporated-multiple-segments-spectacle-lenses-100651827",false,"NCT07765550","Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.\n* Cycloplegic spherical equivalent refraction (SER) of the worse eye \\> -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.\n* Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.\n* At least one parent with SER ≤-3.00D\n\nExclusion Criteria:\n\n* Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).\n* Individuals with known allergies or contraindications to cycloplegic agents.\n* Previous use of myopia management treatment (spectacles, atropine; CLs).\n* Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.\n* Individuals unable to cooperate with examinations or communicate.\n* Any other conditions deemed by the investigator as unsuitable for participation in the study.","ALL","3 Years","6 Years",{"count":73,"type":74},128,"ESTIMATED","INTERVENTIONAL",[77],"NA","Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.",[80,81],"Pre-myopia","Myopia",[83,84,85],"pre-myopia","young children","AI-assisted DIMS-based spectacle lens","NOT_YET_RECRUITING","2026-08-17",{"date":89,"type":90},"2026-08-18","ACTUAL",{"date":92,"type":74},"2026-09-12",{"date":94,"type":74},"2028-08-31",{"name":5,"class":6},1]