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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Vision Disorders
• Intervention / Treatment: Device: EQ103

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newark, California, United States, 94560
      • Recruiting
      • EyeQue
      • Principal Investigator: Noam Sapiens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EyeQue Corp.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2020
• Primary Completion (ANTICIPATED): June 21, 2023
• Study Completion (ANTICIPATED): June 21, 2023

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders
• Other Study ID Numbers: EYEQUE - 004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes