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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorEssilor International

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Photorefraction device under investigation

    Device

    Objective refraction measurement with and without cyclopegia

  • Comparator device, Tabletop auto-refractometer

    Device

    Objective refraction measurement with and without cyclopegia

  • Comparator device, portable photorefraction device

    Device

    Objective refraction measurement with and without cyclopegia

  • Distance visual acuity assessments

    Other intervention

    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 and far visual acuity

    Other intervention

    Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures

  • Strabismus assessment

    Other intervention

    Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.

Treatment groups

315 Participants
are divided into 1 treatment group
Group A: Snapsight photorefraction deviceExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Perfomance evaluation for ametropia screening

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).

Secondary outcomes

1

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.

Time frame
One day (all measurements are taken during a single evaluation visit).
2

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.

Time frame
One day (all measurements are taken during a single evaluation visit).
3

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.

Time frame
One day (all measurements are taken during a single evaluation visit).
4

Safety assessment and device failures

Type, frequency and severity of adverse events and device failures are evaluated

Time frame
One day (all measurements are taken during a single evaluation visit).

Other outcomes

Sponsors and contacts

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