Phase
Condition
Eye Disorders/infections
Treatment
Comparator device, Closed-field autorefractometer
Clinical Study ID
Ages 6-13 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary, willing to follow the protocol, able to read and understand theinformation form and give free and informed consent (for parents/guardian ofchildren 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, +0.75]
Cylindrical refractive error between 0 and 4.00 D on both eyes
Corrected binocular visual acuity in distance vision at least 6/9
Exclusion
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 withstudy assessment
Less than 6 years old, or 13 years old or above at time of informed consent andassent
Amblyopia, Cataract, Strabismus.
Aphakic or pseudophakic (intraocular implant)
Reported severe eye disease involving loss of visual field as in glaucoma, involvingloss of acuity and severe discomfort in low or overly bright environments as inretinitis pigmentosa or reported and treated dry eye.
Self-reported neurological deficits, including a history of epileptic pathology orsensory-motor coordination disorders, vestibular or cerebellar pathology (e.g.,balance disorders, nystagmus)
Any previous ocular surgery, which might have an influence on vision or interferewith 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)
Study Design
Study Description
Connect with a study center
Hong Kong Polytechnic University
Hong Kong,
Hong KongSite Not Available

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