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.
| NCT ID | NCT06882408 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Essilor International |
| Condition | Ametropia |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2025-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 315 participants in total. It began in 2025-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Aranaud Sauer, MD, PhD, FEBO
PRINCIPAL INVESTIGATOR
Hôpital Civil de Strasbourg
Frequently Asked Questions
Who can join the NCT06882408 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Ametropia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06882408 currently recruiting?
Yes, NCT06882408 is actively recruiting participants. Contact the research team at cadonis@essilor.fr for enrollment information.
Where is the NCT06882408 trial being conducted?
This trial is being conducted at Nancy, France, Strasbourg, France.
Who is sponsoring the NCT06882408 clinical trial?
NCT06882408 is sponsored by Essilor International. The principal investigator is Aranaud Sauer, MD, PhD, FEBO at Hôpital Civil de Strasbourg. The trial plans to enroll 315 participants.