Clinical trial NCT04693247: Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Vision Disorders
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
timeFrame: Day 1
Secondary outcomes:
measure: Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings
timeFrame: Day 1
measure: Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings
timeFrame: Day 1
Other outcomes:
Locations:
city: Newark
country: United States
facility: EyeQue
state: California
Study officials:
References: