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

Status

Enrolling

Conditions

Myopia; Refractive Error

Ametropia

Myopia; Astigmatism

Treatments

Other: Strabismus assessment

Other: Subjective refraction and far visual acuity

Device: Comparator device, portable photorefraction device

Other: Distance visual acuity assessments

Device: Photorefraction device under investigation

Device: Comparator device, Tabletop auto-refractometer

Study type

Interventional

Funder types

Industry

Identifiers

NCT06882408

2024-A00780-47 (Other Identifier)

WS10386-EPSS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

315 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

Accepts Healthy Volunteers

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