RecruitingNot ApplicableNCT06882408

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.

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.

Sponsor

Essilor International

Enrollment

315 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ametropia Myopia; Refractive Error Myopia; Astigmatism

Summary

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

Min Age: 3 YearsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Comparator device, Tabletop auto-refractometer, Comparator device, portable photorefraction device, and others for people with ametropia, myopia; astigmatism, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotorefraction device under investigation

Objective refraction measurement with and without cyclopegia

DEVICEComparator device, Tabletop auto-refractometer

Objective refraction measurement with and without cyclopegia

DEVICEComparator device, portable photorefraction device

Objective refraction measurement with and without cyclopegia

OTHERDistance visual acuity assessments

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

OTHERSubjective refraction and far visual acuity

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

OTHERStrabismus assessment

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