Ametropia, Myopia; Astigmatism, Myopia; Refractive Error
Conditions
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.
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 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.
Interventions
DEVICEPhotorefraction device under investigation
Objective refraction measurement with and without cyclopegia
DEVICEComparator device, Tabletop auto-refractometer
Objective refraction measurement with and without cyclopegia
DEVICEComparator device, portable photorefraction device
Objective refraction measurement with and without cyclopegia
OTHERDistance visual acuity assessments
Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
OTHERSubjective refraction and far visual acuity
Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
OTHERStrabismus assessment
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Sponsors
Essilor International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perfomance evaluation for ametropia screening | One day (all measurements are taken during a single evaluation visit). | The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer | One day (all measurements are taken during a single evaluation visit). | The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors. |
| Perfomance evaluation for ametropia screening | One day (all measurements are taken during a single evaluation visit). | The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer. |
| Perfomance evaluation for amblyopia screening | One day (all measurements are taken during a single evaluation visit). | The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus. |
| Safety assessment and device failures | One day (all measurements are taken during a single evaluation visit). | Type, frequency and severity of adverse events and device failures are evaluated |
Countries
France
Contacts
Primary ContactSara Cadoni
Outcome results
None listed