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

Sponsor

EyeQue Corp. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04693247

Collaborator

(none)

Enrollment

Location

Arms

31.7

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors Vision Disorders	Device: EQ103	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Oct 28, 2020

Anticipated Primary Completion Date :

Jun 21, 2023

Anticipated Study Completion Date :

Jun 21, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Refraction with a Hand-held Refraction Device

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

Device: EQ103

Refraction device

Other: Autorefractor

Standard Device

Device: EQ103

Refraction device

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants [Day 1]
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.

Secondary Outcome Measures

Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings [Day 1]
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
Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings [Day 1]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EyeQue	Newark	California	United States	94560

Sponsors and Collaborators

EyeQue Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EyeQue Corp.

ClinicalTrials.gov Identifier:

NCT04693247

Other Study ID Numbers:

EYEQUE - 004

First Posted:

Jan 5, 2021

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Vision Disorders

Refractive Errors

Study Results

No Results Posted as of Aug 22, 2022