[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581427":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":68,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":27,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Essilor International","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13,14,15,16],"Device: SVL","Device: SVL with passive red-light emission","Device: MCL","Device: MCL with passive red-light emission",{"label":18,"type":10,"description":19,"interventionNames":20},"Group B","(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL",[13,14,15,16],[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","SVL","Dispensed to one eye in Year 1",[9,18],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"SVL with passive red-light emission","Dispensed to the contralateral eye in Year 1.",[9,18],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"MCL","Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).",[9,18],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"MCL with passive red-light emission","Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).",[9,18],[41],{"name":42,"affiliation":43,"role":44},"Andrew Tan","Essilor R&D Centre Singapore","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Celine Carimalo","CONTACT","+65 67134617","carimalc@essilor.com.sg",{"name":52,"role":48,"phone":27,"phoneExt":27,"email":53},"Thomas Boudenne","thomas.boudenne@essilor.com",[55],{"facility":43,"status":56,"city":57,"state":27,"zip":27,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Singapore","SG",{"type":60,"coordinates":61},"Point",[62,63],103.85007,1.28967,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":67,"phoneExt":27,"email":50},"67134617",{"type":69,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100581427","clinical-investigation-of-a-novel-spectacle-lens-on-slowing-down-juvenile-myopia-progression-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":80,"type":81},35,"ESTIMATED","INTERVENTIONAL",[84],"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",[87],"Myopia",[89,90,91,92],"Refractive error","Eye disease","Axial length","Myopia control","2025-08-04",{"date":95,"type":96},"2025-08-07","ACTUAL",{"date":98,"type":96},"2025-06-26",{"date":100,"type":81},"2027-12",{"name":5,"class":6},1]