Status:
UNKNOWN
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
Lead Sponsor:
EyeQue Corp.
Conditions:
Refractive Errors
Vision Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields re...
Detailed Description
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields re...
Eligibility Criteria
Inclusion
- Male or Female
- Ages =\>18 y.o. and =\<65 y.o.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Exclusion
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks.
- At the discretion of the investigator: Age strata has achieved minimum evaluable population.
- 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-reported mental illness or condition, including but not limited to:
- claustrophobia, fear of simulators, nyctophobia.
- Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus
- Per subject self-reporting: eye disease, including but not limited to:
- Glaucoma
- Cataracts
- Macular degeneration
- Eye infection (by self-report or observation)
- Keratoconus
- Diabetic neuropathy/retinopathy
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema
- Amblyopia
- Chronic or acute uveitis
- Strabismus
- Astigmatism \> 3 diopters
- Macular hole
- Subjects that:
- Lack physical dexterity to properly operate the EyeQue device.
- Lack the ability to follow instruction
- Lack a command of the English language
- Lack binocular vision
- Are colorblind
- Had eye surgery within the last 12 months (including Lasik)
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04693247
Start Date
October 28 2020
End Date
June 21 2023
Last Update
August 22 2022
Active Locations (1)
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1
EyeQue
Newark, California, United States, 94560