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.

NCT06882408 | Recruiting

• 2 other identifiers: WS10386-EPSS2024-A00780-47
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer

  One day (all measurements are taken during a single evaluation visit).

• Perfomance evaluation for ametropia screening

  One day (all measurements are taken during a single evaluation visit).

• Perfomance evaluation for amblyopia screening

  One day (all measurements are taken during a single evaluation visit).

• Safety assessment and device failures

  One day (all measurements are taken during a single evaluation visit).

Study Arms (1)

Snapsight photorefraction device

EXPERIMENTAL

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

Interventions

Photorefraction device under investigation DEVICE

Objective refraction measurement with and without cyclopegia

Snapsight photorefraction device

Comparator device, Tabletop auto-refractometer DEVICE

Objective refraction measurement with and without cyclopegia

Snapsight photorefraction device

Comparator device, portable photorefraction device DEVICE

Objective refraction measurement with and without cyclopegia

Snapsight photorefraction device

Distance visual acuity assessments OTHER

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

Snapsight photorefraction device

Subjective refraction and far visual acuity OTHER

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

Snapsight photorefraction device

Strabismus assessment OTHER

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

Snapsight photorefraction device

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essilor International: lead

Study Sites (2)

Dr Krafft private practice

Nancy, France, 54000, France

NOT YET RECRUITING

Hôpital civil de Strasbourg

Strasbourg, France, 67091, France

RECRUITING

MeSH Terms

Conditions

Refractive Errors; Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Aranaud Sauer, MD, PhD, FEBO

  Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Cadoni

CONTACT

+33 642665760; cadonis@essilor.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)