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

EyeQue

Status: Enrolling

Conditions: Refractive Errors; Vision Disorders

Treatments: Device: EQ103

Study type: Interventional

Funder types: Industry

Identifiers

NCT04693247

EYEQUE - 004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Refraction with a Hand-held Refraction Device

Active Comparator group

Description:

This is the device that will be compared to a standard device.

Treatment:

Device: EQ103

Autorefractor

Other group

Description:

Standard Device

Treatment:

Device: EQ103