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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2023-06-21

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.

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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.

Conditions

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Refractive Errors Vision Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Tester and subject for BCVA are masked as to which device and trial frames are from.

Study Groups

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Refraction with a Hand-held Refraction Device

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

Group Type ACTIVE_COMPARATOR

EQ103

Intervention Type DEVICE

Refraction device

Autorefractor

Standard Device

Group Type OTHER

EQ103

Intervention Type DEVICE

Refraction device

Interventions

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EQ103

Refraction device

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes