[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581427":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":11,"studyPopulation":11,"armGroups":29,"interventions":43,"overallOfficials":61,"centralContacts":66,"locations":75,"responsibleParty":89,"collaborators":11,"id":91,"slug":11,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":11,"eligibilityCriteria":95,"healthyVolunteers":92,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Essilor International","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Axial Length",null,"From baseline to 12 months",{"measure":10,"description":11,"timeFrame":14},"From 12 months to 24 months",[16,18],{"measure":17,"description":11,"timeFrame":12},"Change in Spherical Equivalent Refraction",{"measure":17,"description":11,"timeFrame":14},{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"RANDOMIZED","PARALLEL","This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.","TREATMENT",{"masking":25,"maskingDescription":11,"whoMasked":26},"DOUBLE",[27,28],"PARTICIPANT","INVESTIGATOR",[30,39],{"label":31,"type":32,"description":33,"interventionNames":34},"Group A","EXPERIMENTAL","(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission",[35,36,37,38],"Device: SVL","Device: SVL with passive red-light emission","Device: MCL","Device: MCL with passive red-light emission",{"label":40,"type":32,"description":41,"interventionNames":42},"Group B","(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL",[35,36,37,38],[44,49,53,57],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DEVICE","SVL","Dispensed to one eye in Year 1",[31,40],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"SVL with passive red-light emission","Dispensed to the contralateral eye in Year 1.",[31,40],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"MCL","Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).",[31,40],{"type":45,"name":58,"description":59,"armGroupLabels":60,"otherNames":11},"MCL with passive red-light emission","Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).",[31,40],[62],{"name":63,"affiliation":64,"role":65},"Andrew Tan","Essilor R&D Centre Singapore","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"Celine Carimalo","CONTACT","+65 67134617","carimalc@essilor.com.sg",{"name":73,"role":69,"phone":11,"phoneExt":11,"email":74},"Thomas Boudenne","thomas.boudenne@essilor.com",[76],{"facility":64,"status":77,"city":78,"state":11,"zip":11,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"RECRUITING","Singapore","SG",{"type":81,"coordinates":82},"Point",[83,84],103.85007,1.28967,{"lat":84,"lon":83},[87],{"name":68,"role":69,"phone":88,"phoneExt":11,"email":71},"67134617",{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100581427",false,"NCT06850168","Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression","Inclusion Criteria:\n\n* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.\n* Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.\n* Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.\n* Best corrected visual acuity better than or equal to +0.10 log MAR (20\u002F25 or better with Snellen).\n* Be in good general health, based on his\u002Fher and parent's\u002Fguardian's knowledge.\n* Agree to wear spectacles for \\>12 hours\u002Fday and at least 6 days\u002Fweek.\n* Willingness and ability to participate in investigation for 2 years and attend scheduled visits.\n\nExclusion Criteria:\n\n* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)\n* Any binocular vision anomalies\n* Amblyopia\n* Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.\n* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.\n* Participation in any clinical investigation within 30 days of the baseline visit.","ALL","6 Years","11 Years",{"count":100,"type":101},35,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:\n\nDoes the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?\n\nResearchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.\n\nParticipants will:\n\n* Wear the study spectacles\n* Visit Essilor R\\&D Centre for follow-up sessions",[107],"Myopia",[109,110,111,112],"Refractive error","Eye disease","Axial length","Myopia control","2025-08-04",{"date":115,"type":116},"2025-08-07","ACTUAL",{"date":118,"type":116},"2025-06-26",{"date":120,"type":101},"2027-12",{"name":5,"class":6},1]