CClinicalTrials.gg
Sign In
Status unknownNCT04693247Updated Aug 22, 2022

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

An interventional study of EQ103 in Refractive Errors and Vision Disorders, sponsored by EyeQue Corp.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by EyeQue Corp. · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Refractive Errors
  • Vision Disorders
03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's planned enrollment of 35 is below the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

EyeQue Corp. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
35 participants (estimated)

Study arms

  • Active comparator
    Refraction with a Hand-held Refraction Device

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

    Device: EQ103

  • Other
    Autorefractor

    Standard Device

    Device: EQ103

Interventions

  • DeviceEQ103

    Refraction device

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. 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

    Time frame: Day 1

  2. 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

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • EyeQue
    Newark, California 94560, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04693247
Lead sponsor
EyeQue Corp.
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Oct 28, 2020
Primary completion
Jun 21, 2023 (estimated)
Completion
Jun 21, 2023 (estimated)
Last update
Aug 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vision Disorders→

Other studies from this sponsor

EyeQue Corp.

Start the discussion