Status:
RECRUITING
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.
Lead Sponsor:
Essilor International
Conditions:
Ametropia
Myopia; Refractive Error
Eligibility:
All Genders
3-8 years
Phase:
NA
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 s...
Detailed 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 invest...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT06882408
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 29 2025
Active Locations (2)
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1
Dr Krafft private practice
Nancy, France, France, 54000
2
Hôpital civil de Strasbourg
Strasbourg, France, France, 67091