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.

Essilor International315 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

315

Conditions

Ametropia Myopia; Refractive Error Myopia; Astigmatism

Interventions

Photorefraction device under investigationDEVICE

Objective refraction measurement with and without cyclopegia

Comparator device, Tabletop auto-refractometerDEVICE

Objective refraction measurement with and without cyclopegia

Comparator device, portable photorefraction deviceDEVICE

Objective refraction measurement with and without cyclopegia

Distance visual acuity assessmentsOTHER

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 acuityOTHER

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

Strabismus assessmentOTHER

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

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.