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.

Last updated: April 28, 2025
Sponsor: Essilor International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Astigmatism

Myopia

Treatment

Comparator device, Tabletop auto-refractometer

Strabismus assessment

Comparator device, portable photorefraction device

Clinical Study ID

NCT06882408
WS10386-EPSS
2024-A00780-47
  • Ages 3-8
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

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 withthe study measures (except strabismus)

  • Under medication that may have an impact on vision or may interfere with studymeasurements

  • Known contraindication to the active substance or to one of the excipients of eyedrops (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 interferewith the study measures

Study Design

Total Participants: 315
Treatment Group(s): 6
Primary Treatment: Comparator device, Tabletop auto-refractometer
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Dr Krafft private practice

    Nancy, 54000
    France

    Site Not Available

  • Hôpital civil de Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

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