Photorefraction device under investigation
DeviceObjective refraction measurement with and without cyclopegia
NCT Number: NCT06882408
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.
Interested in participating?
Request Info3 year–8 year
All sexes
Interventional
Not applicable
Dr Krafft private practice, Nancy, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: One day (all measurements are taken during a single evaluation visit).
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
Time frame: One day (all measurements are taken during a single evaluation visit).
The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.
Time frame: One day (all measurements are taken during a single evaluation visit).
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.
Time frame: One day (all measurements are taken during a single evaluation visit).
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.
Time frame: One day (all measurements are taken during a single evaluation visit).
Type, frequency and severity of adverse events and device failures are evaluated
Contact information is provided by the study sponsor or research team.
Essilor International
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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