[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657453":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":11,"studyPopulation":11,"armGroups":25,"interventions":37,"overallOfficials":47,"centralContacts":52,"locations":62,"responsibleParty":74,"collaborators":11,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Essilor International","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Eye Axial Length",null,"From baseline to 6 months",[14,16,18],{"measure":10,"description":11,"timeFrame":15},"From 6 months to 12 months",{"measure":17,"description":11,"timeFrame":12},"Change in Eye Non-Cycloplegic Spherical Equivalent Refraction",{"measure":17,"description":11,"timeFrame":15},{"allocation":20,"interventionModel":21,"interventionModelDescription":11,"primaryPurpose":22,"observationalModel":11,"timePerspective":11,"maskingInfo":23},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":24,"maskingDescription":11,"whoMasked":11},"NONE",[26,33],{"label":27,"type":28,"description":29,"interventionNames":30},"OD: SVL; OS: MCL then OD: MCL; OS: SVL","EXPERIMENTAL","Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.",[31,32],"Device: Investigational Myopia Control Spectacle Lens","Device: Single Vision Spectacle Lens",{"label":34,"type":28,"description":35,"interventionNames":36},"OD: MCL; OS: SVL then OD: SVL; OS: MCL","Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.",[31,32],[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"DEVICE","Investigational Myopia Control Spectacle Lens","A spectacle lens designed to help slow the progression of myopia in children",[34,27],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"Single Vision Spectacle Lens","A standard spectacle lens used to correct refractive error without a specific myopia control feature",[34,27],[48],{"name":49,"affiliation":50,"role":51},"Andrew Tan","Essilor R&D Centre Singapore","PRINCIPAL_INVESTIGATOR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Celine Carimalo","CONTACT","67134617","+65","carimalc@essilor.com.sg",{"name":60,"role":55,"phone":11,"phoneExt":11,"email":61},"Thomas Boudenne","thomas.boudenne@essilor.com",[63],{"facility":50,"status":11,"city":64,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Singapore","SG",{"type":67,"coordinates":68},"Point",[69,70],103.85007,1.28967,{"lat":70,"lon":69},[73],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},{"type":75,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657453","comparing-myopia-control-spectacle-lenses-and-standard-single-vision-spectacle-lenses-in-children-with-myopia-100657453",false,"NCT07839091","Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia","A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children","PEARL","Inclusion Criteria:\n\n1. Volunteer participant with the willingness and ability to comply with all scheduled study visits.\n2. Informed consent of parent\u002Fguardian and assent of participant.\n3. Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.\n4. Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.\n5. Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.\n6. Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.\n7. Be in good general health, based on the participant and the parent's\u002Fguardian's knowledge.\n8. Agree to wear the study spectacles for 12 hours per day and 7 days per week.\n9. Agree not to be involved in other myopia control treatments.\n\nExclusion Criteria:\n\n1. History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.\n2. Strabismus by cover test at near or distance wearing correction.\n3. History and presence of amblyopia.\n4. Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).\n5. Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.\n6. History of ocular injury or surgery.\n7. Participation in any clinical study within 30 days of the Baseline visit.\n8. Current or anticipated use of growth hormones.\n9. Study participants deemed inappropriate for the study by the investigator.\n10. The inherent ocular\u002Fsystemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.","ALL","6 Years","10 Years",{"count":88,"type":89},20,"ESTIMATED","INTERVENTIONAL",[92],"NA","The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.\n\nThe main question being studied is:\n\nIs the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?\n\nIn this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.\n\nParticipants will:\n\n* Wear the study spectacles for 12 months.\n* Attend scheduled follow-up visits at the Essilor R\\&D Centre, Singapore.",[95,96],"Myopia","Myopia Progression",[98,99,100],"refractive error","myopia control","axial length","NOT_YET_RECRUITING","2026-09-18",{"date":104,"type":105},"2026-09-24","ACTUAL",{"date":107,"type":89},"2026-10",{"date":109,"type":89},"2028-07",{"name":5,"class":6},1]