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NCT Number: NCT06882408

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.

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.

Recruiting

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Krafft private practice, Nancy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photorefraction device under investigation

Device

Objective refraction measurement with and without cyclopegia

Comparator device, Tabletop auto-refractometer

Device

Objective refraction measurement with and without cyclopegia

Comparator device, portable photorefraction device

Device

Objective refraction measurement with and without cyclopegia

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.

Subjective refraction and far visual acuity

Other

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

Strabismus assessment

Other

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

Primary outcomes

  1. Perfomance evaluation for ametropia screening

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

    The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.

Secondary outcomes

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

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

    The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.

  2. Perfomance evaluation for ametropia screening

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

    The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.

  3. Perfomance evaluation for amblyopia screening

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

    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.

  4. Safety assessment and device failures

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

    Type, frequency and severity of adverse events and device failures are evaluated

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Cadoni

CONTACT

[email protected]

+33 642665760

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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