Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

Study Overview
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Brief Summary
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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 results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Detailed Description
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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 results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Official Title
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An Exploratory Study in Healthy Adult Volunteers to Evaluate the Best Corrected Visual Acuity (BCVA) Performance of a Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

Conditions
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Vision Disorders, Refractive Errors

Intervention / Treatment
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* Device: EQ103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Refraction with a Hand-held Refraction Device<br>This is the device that will be compared to a standard device. | Device: EQ103<br>* Refraction device<br>|
| Other: Autorefractor<br>Standard Device | Device: EQ103<br>* Refraction device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for each eye (pooled) from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata. o Age Groups: 18 - 29, 30 - 44, 45 - 65 | Day 1 | 
| Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for worse eye from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata. o Age Groups: All, 18 - 29, 30 - 44, 45 - 65 | Day 1 |