Evaluating a device for screening vision problems in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the performance of a photorefraction device in screening for ametropia in children aged 3 to 8 years. Participants will undergo multiple refractive error measurements, visual acuity tests, and strabismus assessments during a single visit. The study compares the results from the investigational device with those obtained from a gold standard tabletop refractometer to evaluate sensitivity, specificity, and accuracy. The trial includes children who wear glasses or do not, ensuring a comprehensive assessment of the device's effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital civil de Strasbourg
  Strasbourg, France, France Recruiting
• Dr Krafft private practice
  Nancy, France, France Not yet recruiting

Study contacts

• Principal investigator: Aranaud Sauer, MD, PhD, FEBO — Hôpital Civil de Strasbourg
• Study coordinator: Sara Cadoni
• Email: cadonis@essilor.fr
• Phone: +33 642665760

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.