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.

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.

Study Overview

• Status: Recruiting
• Conditions: Ametropia; Myopia; Refractive Error; Myopia; Astigmatism
• Intervention / Treatment: Device: Photorefraction device under investigation; Device: Comparator device, Tabletop auto-refractometer; Device: Comparator device, portable photorefraction device; Other: Distance visual acuity assessments; Other: Subjective refraction and far visual acuity; Other: Strabismus assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 315
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Cadoni; Phone Number: +33 642665760; Email: cadonis@essilor.fr

Study Locations

• France
  • Nancy, France, 54000
    • Not yet recruiting
    • Dr Krafft private practice
    • Contact: Véronique Krafft; Phone Number: +336 09 91 93 74; Email: veronique.krafft@me.com
  • Strasbourg, France, 67091
    • Recruiting
    • Hôpital Civil de Strasbourg
    • Contact: Arnaud Sauer; Phone Number: +33369550270; Email: arnaud.sauer@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Snapsight photorefraction device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfomance evaluation for ametropia screening	The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.	One day (all measurements are taken during a single evaluation visit).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer	The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.	One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for ametropia screening	The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.	One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for amblyopia screening	The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus.	One day (all measurements are taken during a single evaluation visit).
Safety assessment and device failures	Type, frequency and severity of adverse events and device failures are evaluated	One day (all measurements are taken during a single evaluation visit).

Collaborators and Investigators

• Sponsor: Essilor International
• Investigators: Principal Investigator: Aranaud Sauer, MD, PhD, FEBO, Hôpital Civil de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Astigmatism; Refractive Errors
• Other Study ID Numbers: WS10386-EPSS; 2024-A00780-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No