[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571191":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Singapore National Eye Centre","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Children on clear DIMS lenses","ACTIVE_COMPARATOR","202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.",[13],"Device: EYE001",{"label":15,"type":10,"description":11,"interventionNames":16},"Children on photochromic DIMS lenses",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","EYE001","Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic",[9,15],[24],"Defocus incorporated multiple segments (DIMS) lenses",null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Bryan Sim, MD FRCOphth (UK)","CONTACT","+6597722192","bryansimxr@hotmail.com",[33],{"facility":5,"status":25,"city":34,"state":25,"zip":35,"country":34,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Singapore","159029","SG",{"type":38,"coordinates":39},"Point",[40,41],103.85007,1.28967,{"lat":41,"lon":40},[44],{"name":45,"role":29,"phone":46,"phoneExt":25,"email":31},"Bryan Sim, MBBS FRCOphth","97722192",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Bryan Sim XR","Consultant","100571191","evaluation-of-performance-of-miyosmart-photochromic-and-clear-spectacle-lenses-in-myopic-children-100571191",false,"NCT06717035","Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children","Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children.","PDIMS","Inclusion Criteria\n\nSubjects must meet all the criteria listed to participate in the study:\n\n1. All ethnicities\n2. Age between 6 and 15 years\n3. Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D\n4. Anisometropia ≤ 3.00D\n5. Best corrected monocular distance high contrast VA ≤ 0.10 logMAR\n6. Normal Binocular vision (fusion and stereopsis)\n\nExclusion Criteria\n\nAll subjects meeting any of the exclusion criteria at baseline will be excluded from participation:\n\n1. Ocular and systemic abnormalities\n2. Children who do not cooperate\n3. Binocular vision anomalies (strabismus, suppression)\n4. Previous use of myopia management treatment (spectacles, atropine, CLs)\n5. Neurological disorders\n6. Premature infants\n7. Children who do not wear their glasses correctly for intermediate and near vision activities\n8. Children who do not meet the inclusion criteria\n9. No informed consent given by parents of child for participation in the clinical study\n10. Subject is allergic to cycloplegic eye drops","ALL","6 Years","15 Years",{"count":63,"type":64},202,"ESTIMATED","INTERVENTIONAL",[67],"NA","This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.",[70,71],"Myopia","Myopia Progression",[70,73,74,75,76,77],"Spectacles","Glasses","Myopia Control","Pediatric","DIMS","NOT_YET_RECRUITING","2024-11-29",{"date":81,"type":82},"2024-12-04","ACTUAL",{"date":84,"type":64},"2025-01-02",{"date":86,"type":64},"2027-01-02",{"name":5,"class":6},1]