Evaluating a device for screening vision problems in young children
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.
This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 2 sites (Nancy, France and 1 other locations) |
| Trial ID | NCT06882408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 years, regardless of whether they wear glasses.
Not a fit: Patients with ocular or systemic pathologies affecting vision or those currently using contact lenses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for refractive errors in children, facilitating early detection and treatment.
How similar studies have performed: Other studies have shown promise in using photorefraction devices for screening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nancy, France and 1 other locations
- Dr Krafft private practice — Nancy, France, France (Not_yet_recruiting)
- Hôpital civil de Strasbourg — Strasbourg, France, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.