Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India

Essilor

Status

Completed

Conditions

Ametropia

Treatments

Device: Comparator device, Closed-field autorefractometer with cycloplegia

Other: Distance visual acuity check using objective refraction with cycloplegia

Other: Distance visual acuity check using objective refraction without cycloplegia

Device: Comparator device, Closed-field autorefractometer without cycloplegia

Study type

Interventional

Funder types

Industry

Identifiers

NCT06524115

WS10364

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 patients

Sex

All

Ages

6 to 13 years old

Volunteers

Accepts Healthy Volunteers

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)