About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Photorefraction device under investigation
DeviceObjective refraction measurement with and without cyclopegia
Comparator device, Tabletop auto-refractometer
DeviceObjective refraction measurement with and without cyclopegia
Comparator device, portable photorefraction device
DeviceObjective refraction measurement with and without cyclopegia
Distance visual acuity assessments
Other interventionDistance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Subjective refraction and far visual acuity
Other interventionSubjective refraction is assessed and far visual acuity is assessed with the found refraction measures
Strabismus assessment
Other interventionStrabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Treatment groups
Trial outcomes
Primary outcomes
Perfomance evaluation for ametropia screening
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
Secondary outcomes
Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer
The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.
Perfomance evaluation for ametropia screening
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.
Perfomance evaluation for amblyopia screening
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus.
Safety assessment and device failures
Type, frequency and severity of adverse events and device failures are evaluated
Sponsors and contacts
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