[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Indizen Optical Technologies, S.L.U.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":21,"type":22},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",[27],"Myopia Progression","NOT_YET_RECRUITING","2026-03-03",{"date":31,"type":32},"2026-03-05","ACTUAL",{"date":34,"type":22},"2026-04",{"date":36,"type":22},"2028-10",{"name":38,"class":39},"Indizen Optical Technologies, S.L.U.","INDUSTRY",3,""]