[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628535":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Essilor International","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"OD: MCL 1; OS: MCL 2","EXPERIMENTAL","Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.",[13,14],"Device: MCL1","Device: MCL2",{"label":16,"type":10,"description":17,"interventionNames":18},"OD: MCL 2; OS: MCL 1","Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","MCL1","Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"MCL2","Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Thibaut Chapron, MD","CONTACT","00331 48 03 65 56","tchapron@for.paris",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild","RECRUITING","Paris","75019","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":52,"phoneExt":25,"email":35},"+33.1.48.03.65.56",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100628535","evaluation-of-the-effectiveness-of-a-new-generation-of-myopia-control-lens-on-the-progression-of-myopia-in-children-aged-6-to-14-years-100628535",false,"NCT07462897","Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years","Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years","VERCORS","Inclusion Criteria:\n\n* Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)\n* Astigmatism ≤ 2.00 D for each eye\n* Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D\n* Corrected maximum distance visual acuity in each eye≥ 8\u002F10 (equivalent to +0.1 LogMAR)\n* Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant\n\nExclusion Criteria:\n\n* Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc\n* Strabismus (in the test of masking near or far with the best correction)\n* Amblyopia\n* Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)\n* Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye\n* History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye\n* Past or current use of growth hormones\n* Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.\n* Wearing contact lenses\n* Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)\n* Known allergy or intolerance to eyeglass frame materials\n* Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.\n* Intolerance to conventional optical corrections\n* Lack of cooperation in wearing corrective lenses","ALL","6 Years","14 Years",{"count":67,"type":68},76,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality.\n\nParticipants will:\n\n* Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;\n* Visit the hospital at 6 and 12 months for tests;\n* Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.",[74],"Myopia Progression","2026-04-20",{"date":77,"type":78},"2026-04-23","ACTUAL",{"date":80,"type":78},"2026-03-18",{"date":82,"type":68},"2028-05",{"name":5,"class":6},1]