[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623278":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":66,"collaborators":68,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":89,"studyType":90,"phases":7,"briefSummary":91,"conditions":92,"keywords":7,"overallStatus":94,"whyStopped":7,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Indizen Optical Technologies, S.L.U.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"OTHER","myopia control lens","Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Eva Chamorro Guitierrez","CONTACT","+34(91) 8333786","evachamorro@iot.es",[20,36,51],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Universidade Do Minho","Braga","Portugal","PT",{"type":26,"coordinates":27},"Point",[28,29],-8.42311,41.5514,{"lat":29,"lon":28},[32],{"name":33,"role":16,"phone":34,"phoneExt":7,"email":35},"José Manuel Gonzalez Meijome","+351253604072","jgmeijome@fisica.uminho.pt",{"facility":37,"status":7,"city":38,"state":7,"zip":7,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"Hospital Universitario Clínico San Carlos","Madrid","Spain","ES",{"type":26,"coordinates":42},[43,44],-3.70256,40.4165,{"lat":44,"lon":43},[47],{"name":48,"role":16,"phone":49,"phoneExt":7,"email":50},"Noemi Güemes Villahoz","+34 (91)3303000","noemiguemes@gmail.com",{"facility":52,"status":7,"city":53,"state":7,"zip":7,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Ulster University","Coleraine","United Kingdom","UK",{"type":26,"coordinates":57},[58,59],-6.66667,55.13333,{"lat":59,"lon":58},[62],{"name":63,"role":16,"phone":64,"phoneExt":7,"email":65},"Kathryn Sanders","+442870123456","kj.saunders@ulster.ac.uk",{"type":67,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[69,71,73],{"name":70,"class":10},"Hospital San Carlos, Madrid",{"name":72,"class":10},"University of Minho",{"name":74,"class":10},"University of Ulster","100623278","prospective-research-on-the-intervention-of-myoless20-effectiveness-prime-in-pediatric-population-100623278",false,"NCT07394556","Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population","PRIME","Inclusion Criteria:\n\n* Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.\n* For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.\n* Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.\n* Be accompanied by parents\u002Fguardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.\n* Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.\n* Have ocular health findings considered to be \"normal\".\n* Be correctable to at least 6\u002F9.5 (20\u002F30) or better in each eye with spectacles.\n* Be willing to wear the spectacles provided by the investigators for all waking hours.\n\nExclusion Criteria:\n\n* A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.\n* Had strabismus and\u002For amblyopia.\n* Cylinder more than -2.00D\n* Anisometropia greater than 1.50D spherical equivalent\n* Had previous eye surgery (including strabismus surgery).\n* Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.\n* Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.\n* Current orthoptic treatment or vision training.\n* Any anatomical, skin or other condition that would impact on the wearing of spectacles.\n* Use of or need for concurrent category S3 and above ocular medication at enrolment and\u002For during the clinical trial.\n* Currently enrolled in another clinical trial.\n* No previous myopia management intervention or treatment.",true,"ALL","6 Years","12 Years",{"count":87,"type":88},180,"ESTIMATED","24 Months","OBSERVATIONAL","The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).\n\nGroup 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months",[93],"Myopia Progression","NOT_YET_RECRUITING","2026-03-03",{"date":97,"type":98},"2026-03-05","ACTUAL",{"date":100,"type":88},"2026-04",{"date":102,"type":88},"2028-10",{"name":5,"class":6},3]