[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655150":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":32,"interventions":39,"overallOfficials":45,"centralContacts":50,"locations":11,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":11},{"fullName":5,"class":6},"Essilor International","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in the Cylinder value through non cycloplegic autorefraction",null,"12 months",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Change from baseline in the Keratometry value measured using a Keratometer",{"measure":17,"description":11,"timeFrame":12},"Change from baseline in the Axial Length value measured using a biometer",{"measure":19,"description":20,"timeFrame":21},"Quality of Life while wearing the study lenses measured through Questionnaire","PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall.\n\nThe Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree\n\nThe parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes","Baseline, 6 and 12 months",[23],{"measure":24,"description":11,"timeFrame":25},"Safety: Change from baseline in the Axial Length value measured using a biometer","3 and 6 months",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":29,"observationalModel":11,"timePerspective":11,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":11,"whoMasked":11},"NONE",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Myopia Control Lens Prototype","EXPERIMENTAL","Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements.\n\nDevice Details:\n\nThe myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period.",[38],"Device: Lenslet-based myopia control spectacle lens",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"DEVICE","Lenslet-based myopia control spectacle lens","Device Details:\n\nThe myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings.",[34],[46],{"name":47,"affiliation":48,"role":49},"Si Ying Lim","EssilorLuxottica","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},"Celine Carimalo","CONTACT","+65 67134600","carimalc@essilor.com.sg",{"name":57,"role":53,"phone":11,"phoneExt":11,"email":58},"Thomas Boudenne","thomas.boudenne@essilor.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655150","effect-of-a-myopia-control-lens-on-the-astigmatism-in-children-100655150",false,"NCT07810725","Effect of a Myopia Control Lens on the Astigmatism in Children","A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child","MAC","Inclusion Criteria:\n\n* Volunteer participant\n* Informed consent of parent or guardian and assent of participant\n* Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.\n* Refractive error (manifest refraction):\n\n  * With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)\n  * Astigmatism should be more than or equal to 1.50D\n  * Least myopic meridian equal or less than -0.50D\n  * Most myopic meridian equal or greater than -5.50D.\n  * Anisometropia should be less than or equal to 1.00D\n* Best corrected visual acuity: Better than 0.2 logMAR in each eye\n* Willingness and ability to:\n\n  * participate in trial for at least 12 months.\n  * attend scheduled visits.\n  * not to be involved in other myopia control treatments concurrently.\n* No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)\n\nExclusion Criteria:\n\n* History or presence of:\n\n  * An ocular disease\n  * Strabismus\n  * Amblyopia","ALL","6 Years","13 Years",{"count":73,"type":74},15,"ESTIMATED","INTERVENTIONAL",[27],"The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.\n\nThe main question it aims to answer is:\n\n\\- How does the eye respond at each timepoint to the myopia control lenses?\n\nBy evaluating: the change in astigmatism (cylinder) after one year?\n\nParticipants will:\n\nWear the assigned study spectacles daily\n\nVisit the Essilor R\\&D Centre for scheduled follow-up sessions",[79,80],"Astigmatism","Myopia",[82,79,83,84],"Myopia control","axial length","cylinder","NOT_YET_RECRUITING","2026-09-10",{"date":88,"type":89},"2026-09-15","ACTUAL",{"date":91,"type":74},"2026-09",{"date":93,"type":74},"2028-03-01",{"name":5,"class":6}]