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

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

Treatments tested in this trial

  • Photorefraction device under investigation
  • Comparator device, Tabletop auto-refractometer
  • Comparator device, portable photorefraction device
  • Distance visual acuity assessments
  • Subjective refraction and far visual acuity
  • Strabismus assessment

Treatment groups

315 Participants
are divided into 1 treatment group

Sponsors and collaborators