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.
Essilor International
315 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Aged between 3-8 years when included in the study
- All skin phototypes (I to VI according to the Fitzpatrick classification)
- Wearing glasses or not
- Capacity to give valid consent
- Capacity to follow the protocol to obtain reliable measure
- Under French medical insurance
Exclusion Criteria7
- Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
- Wearing contact lenses
- Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
- Under medication that may have an impact on vision or may interfere with study measurements
- Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
- Known risk of angle-closure glaucoma
- Participation to another study that may have an impact on vision or may interfere with the study measures
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Objective refraction measurement with and without cyclopegia
Objective refraction measurement with and without cyclopegia
Objective refraction measurement with and without cyclopegia
Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06882408