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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.
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: * Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer. * Assess the agreement of the measures obtained with the device with those obtained with the gold standard.
Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.
Age
3 - 8 years
Sex
ALL
Healthy Volunteers
Yes
Dr Krafft private practice
Nancy, France, France
Hôpital civil de Strasbourg
Strasbourg, France, France
Start Date
April 1, 2025
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
April 29, 2025
315
ESTIMATED participants
Photorefraction device under investigation
DEVICE
Comparator device, Tabletop auto-refractometer
DEVICE
Comparator device, portable photorefraction device
DEVICE
Distance visual acuity assessments
OTHER
Subjective refraction and far visual acuity
OTHER
Strabismus assessment
OTHER
Lead Sponsor
Essilor International
NCT07322211
NCT06631339
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07155551