[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623278":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":63,"collaborators":65,"id":72,"slug":7,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":7,"briefSummary":87,"conditions":88,"keywords":7,"overallStatus":90,"whyStopped":7,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[20,35,49],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"Universidade Do Minho","Braga","Portugal",{"type":25,"coordinates":26},"Point",[27,28],-8.42311,41.5514,{"lat":28,"lon":27},[31],{"name":32,"role":16,"phone":33,"phoneExt":7,"email":34},"José Manuel Gonzalez Meijome","+351253604072","jgmeijome@fisica.uminho.pt",{"facility":36,"status":7,"city":37,"state":7,"zip":7,"country":38,"cosmosGeoPoint":39,"geoPoint":43,"contacts":44},"Hospital Universitario Clínico San Carlos","Madrid","Spain",{"type":25,"coordinates":40},[41,42],-3.70256,40.4165,{"lat":42,"lon":41},[45],{"name":46,"role":16,"phone":47,"phoneExt":7,"email":48},"Noemi Güemes Villahoz","+34 (91)3303000","noemiguemes@gmail.com",{"facility":50,"status":7,"city":51,"state":7,"zip":7,"country":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Ulster University","Coleraine","United Kingdom",{"type":25,"coordinates":54},[55,56],-6.66667,55.13333,{"lat":56,"lon":55},[59],{"name":60,"role":16,"phone":61,"phoneExt":7,"email":62},"Kathryn Sanders","+442870123456","kj.saunders@ulster.ac.uk",{"type":64,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[66,68,70],{"name":67,"class":10},"Hospital San Carlos, Madrid",{"name":69,"class":10},"University of Minho",{"name":71,"class":10},"University of Ulster","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":83,"type":84},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",[89],"Myopia Progression","NOT_YET_RECRUITING","2026-03-03",{"date":93,"type":94},"2026-03-05","ACTUAL",{"date":96,"type":84},"2026-04",{"date":98,"type":84},"2028-10",{"name":5,"class":6},3]