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.

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.

Conditions

• Ametropia
• Myopia; Refractive Error
• Myopia; Astigmatism

Interventions

DEVICE

Photorefraction device under investigation

Objective refraction measurement with and without cyclopegia

DEVICE

Comparator device, Tabletop auto-refractometer

Objective refraction measurement with and without cyclopegia

DEVICE

Comparator device, portable photorefraction device

Objective refraction measurement with and without cyclopegia

OTHER

Distance 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.

OTHER

Subjective refraction and far visual acuity

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

OTHER

Strabismus assessment

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

Sponsors & Collaborators

• Essilor International

  lead INDUSTRY

Principal Investigators

• Aranaud Sauer, MD, PhD, FEBO · Hôpital Civil de Strasbourg

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• France

Study Locations