Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthal… (NCT04955379) | Clinical Trial Compass
UnknownNot Applicable
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
Israel50 participantsStarted 2021-12-15
Plain-language summary
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female
* Ages ≥6 y.o. and \<18 y.o.
* Binocular vision
* Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
* Subject able to follow all study procedures and requirements
Exclusion Criteria:
* Spherical correction \> +8 or \< -10
* Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study.
* Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study.
* Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the EyeQue EQ103 device,
* Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
* Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.
* Any self/caregiver-reported glaucoma diagnosis of the subject.
* Eye disease, including but not limited to:
* Cataracts
* Macular degeneration
* Eye infection (by self-report or observation)
* Keratoconus
* Diabetic neuropathy/retinopathy
* Cytomegalovirus retinitis
* Color blindness (any color deficiency)
* Diabetic macular edema
* Amb…
What they're measuring
1
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)