Ametropia
Conditions
Brief summary
The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.
Detailed description
A single visit will be necessary. After informed consent, and checking of the inclusion and exclusion criteria, investigators will perform measurements with an autorefractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an autorefractometer under cyclopegia.
Interventions
DEVICEComparator device, Closed-field autorefractometer without cycloplegia
Objective refraction without cycloplegia
OTHERDistance visual acuity check using objective refraction without cycloplegia
Distance visual acuity is checked, using objective refraction without cycloplegia
DEVICEComparator device, Closed-field autorefractometer with cycloplegia
Objective refraction with cycloplegia
OTHERDistance visual acuity check using objective refraction with cycloplegia
Distance visual acuity is checked, using objective refraction with cycloplegia
Sponsors
Essilor International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old * At least 6 years old and up to 12 years old at time of informed consent and assent * Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval \[-10.00, +8.00\] * Cylindrical refractive error between 0 and 4.00 D on both eyes * Corrected binocular visual acuity in distance vision at least 6/9
Exclusion criteria
* Incapable of expressing consent * All categories of persons particularly protected by law * Subject in another study which might have an influence on vision or interfere with study assessment * Less than 6 years old, or 13 years old or above at time of informed consent and assent * Amblyopia, Cataract, Strabismus. * Aphakic or pseudophakic (intraocular implant) * Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye. * Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) * Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…), * Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective refractive error | One day (all measurements are taken during the single visit) | The refractive error is collected in sphere power (D), cylinder power (D) and cylinder axis (°) and converted in equivalent sphere, J0, J45 (power vector in D) |
Countries
India
Outcome results
None listed