Overview
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.
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 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.
Eligibility
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