[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583905":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":89,"collaborators":11,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":11,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"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",[56,74],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":60,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Dr Krafft private practice","NOT_YET_RECRUITING","Nancy","France","54000","FR",{"type":64,"coordinates":65},"Point",[66,67],6.18496,48.68439,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":11,"email":73},"Véronique Krafft","+336 09 91 93 74","veronique.krafft@me.com",{"facility":75,"status":76,"city":77,"state":60,"zip":78,"country":60,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hôpital civil de Strasbourg","RECRUITING","Strasbourg","67091",{"type":64,"coordinates":80},[81,82],7.74553,48.58392,{"lat":82,"lon":81},[85],{"name":86,"role":52,"phone":87,"phoneExt":11,"email":88},"Arnaud Sauer","+33369550270","arnaud.sauer@chru-strasbourg.fr",{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100583905","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-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":103,"type":104},315,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110,111,112],"Ametropia","Myopia; Refractive Error","Myopia; Astigmatism","2025-04-28",{"date":115,"type":116},"2025-04-29","ACTUAL",{"date":118,"type":104},"2025-04",{"date":120,"type":104},"2025-12",{"name":5,"class":6},2]