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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ametropia Myopia; Refractive Error Myopia; Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Snapsight photorefraction device

Group Type EXPERIMENTAL

Photorefraction device under investigation

Intervention Type DEVICE

Objective refraction measurement with and without cyclopegia

Comparator device, Tabletop auto-refractometer

Intervention Type DEVICE

Objective refraction measurement with and without cyclopegia

Comparator device, portable photorefraction device

Intervention Type DEVICE

Objective refraction measurement with and without cyclopegia

Distance visual acuity assessments

Intervention Type OTHER

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 acuity

Intervention Type OTHER

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

Strabismus assessment

Intervention Type OTHER

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

Interventions

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Photorefraction device under investigation

Objective refraction measurement with and without cyclopegia

Intervention Type DEVICE

Comparator device, Tabletop auto-refractometer

Objective refraction measurement with and without cyclopegia

Intervention Type DEVICE

Comparator device, portable photorefraction device

Objective refraction measurement with and without cyclopegia

Intervention Type DEVICE

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.

Intervention Type OTHER

Subjective refraction and far visual acuity

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

Intervention Type OTHER

Strabismus assessment

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes