Phase
Condition
Eye Disorders/infections
Eye Disease
Astigmatism
Treatment
Non-cycloplegic Retinoscopy
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Clinical Study ID
Ages 6-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age between 6 and 12 years
Subject able to recognize and name the letters of the Latin alphabet
Pupillary distance (PD) not less than 49mm
Distance refractive error for spherical equivalence (SE) within the range of [-6.00to +6.00 D] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D
Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
Visual acuity difference < 0.20 logMAR between right and left eyes at distance
Exclusion
Exclusion Criteria:
Vulnerability of the subject
Amblyopia
Strabismus
Any current or evolving pathology manifested in the eye or the appendages whichmight have an influence on vision, or interfere with refractive state
Any previous ocular surgery, which might have an influence on vision or interferewith study assessments (e.g. iridectomy, refractive surgery...)
Any ocular or systemic condition known to affect refractive status (e.g.,keratoconus, diabetes, Down's syndrome, etc.)
Any neurological or speech disorders that might interfere with the ability tounderstand and answer questions or communicate with the ECP
Any untreated and/or uncontrolled systemic condition which might have an influenceon vision or interfere with study assessments
Current use of ocular or systemic medications, which, in the Investigator's opinion,may significantly affect pupil size, accommodation or refractive state
History of myopia control intervention that may affect refractive assessment (e.g.,atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopiacontrol spectacles
Contraindications of cycloplegia (e.g. high Intra-ocular pressure - more than 22mmHgin either eye, narrow anterior angle, history of allergy to cycloplegic agents orseizures, etc)
Aphakic or pseudoaphakic (intraocular lens),
Prismatic prescription in either Right or Left eye (horizontal or vertical). -
Study Design
Study Description
Connect with a study center
Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova De Famalicão, 4764-502
PortugalActive - Recruiting

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