[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583905":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":88,"collaborators":11,"id":90,"slug":11,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":11,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Essilor International","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Snapsight photorefraction device","EXPERIMENTAL",null,[13,14,15,16,17,18],"Device: Photorefraction device under investigation","Device: Comparator device, Tabletop auto-refractometer","Device: Comparator device, portable photorefraction device","Other: Distance visual acuity assessments","Other: Subjective refraction and far visual acuity","Other: Strabismus assessment",[20,25,28,31,36,40],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Photorefraction device under investigation","Objective refraction measurement with and without cyclopegia",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Comparator device, Tabletop auto-refractometer",[9],{"type":21,"name":29,"description":23,"armGroupLabels":30,"otherNames":11},"Comparator device, portable photorefraction device",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"OTHER","Distance visual acuity assessments","Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.",[9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Subjective refraction and far visual acuity","Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures",[9],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Strabismus assessment","Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.",[9],[45],{"name":46,"affiliation":47,"role":48},"Aranaud Sauer, MD, PhD, FEBO","Hôpital Civil de Strasbourg","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Sara Cadoni","CONTACT","+33 642665760","cadonis@essilor.fr",[56,73],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":60,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Dr Krafft private practice","NOT_YET_RECRUITING","Nancy","France","54000",{"type":63,"coordinates":64},"Point",[65,66],6.18496,48.68439,{"lat":66,"lon":65},[69],{"name":70,"role":52,"phone":71,"phoneExt":11,"email":72},"Véronique Krafft","+336 09 91 93 74","veronique.krafft@me.com",{"facility":74,"status":75,"city":76,"state":60,"zip":77,"country":60,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hôpital civil de Strasbourg","RECRUITING","Strasbourg","67091",{"type":63,"coordinates":79},[80,81],7.74553,48.58392,{"lat":81,"lon":80},[84],{"name":85,"role":52,"phone":86,"phoneExt":11,"email":87},"Arnaud Sauer","+33369550270","arnaud.sauer@chru-strasbourg.fr",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100583905",false,"NCT06882408","The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.","Evaluation of the Photorefraction Screener Snapsight in Comparison With Cycloplegia Table-top Autorefractor in Ametropia in Pediatric Population Between 3 and 8yo, Multicenter French Study.","Inclusion Criteria:\n\n* Aged between 3-8 years when included in the study\n* All skin phototypes (I to VI according to the Fitzpatrick classification)\n* Wearing glasses or not\n* Capacity to give valid consent\n* Capacity to follow the protocol to obtain reliable measure\n* Under French medical insurance\n\nExclusion Criteria:\n\n* Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)\n* Wearing contact lenses\n* Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)\n* Under medication that may have an impact on vision or may interfere with study measurements\n* Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)\n* Known risk of angle-closure glaucoma\n* Participation to another study that may have an impact on vision or may interfere with the study measures",true,"ALL","3 Years","8 Years",{"count":101,"type":102},315,"ESTIMATED","INTERVENTIONAL",[105],"NA","The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:\n\n* Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer.\n* Assess the agreement of the measures obtained with the device with those obtained with the gold standard.",[108,109,110],"Ametropia","Myopia; Refractive Error","Myopia; Astigmatism","2025-04-28",{"date":113,"type":114},"2025-04-29","ACTUAL",{"date":116,"type":102},"2025-04",{"date":118,"type":102},"2025-12",{"name":5,"class":6},2]