search
Back to results

EyeQue VisionCheck 510(k) Clinical Trial

Primary Purpose

Refractive Errors, Astigmatism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EyeQue VisionCheck
Phoropter
Sponsored by
EyeQue Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Refractive Errors focused on measuring Myopia, Hyperopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Each participant must meet the following criteria to be enrolled in this study: Participant or legally authorized representative (LAR) is willing and able to give informed consent Participant is willing and able to follow all study procedures and requirements Participant is able to use a smartphone Participant is interested in getting refraction correction measurement Participant is able to speak, read and write English fluently Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: Spherical correction >+8D or <-10D (outside the range of the VisionCheck measurement) Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement) Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement) Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect vision within the greater of three days or five half-lives prior to enrolling in this study Using an investigational drug or approved therapy for investigational use within the greater of three days or five half-lives prior to enrolling in this study Color deficiency (Ishihara pseudoisochromatic plates: Concise 14-plate edition: six or more errors on plates 1-11; the 24-plate edition: seven or more errors on plates 1-15; the 38-plate edition: nine or more errors on plates 1-21) Neurological and developmental conditions that may affect the outcome of the trial including, but not limited to, Multiple Sclerosis (MS), Stroke, Traumatic Brain Injury (TBI), Parkinson's Disease, Alzheimer's Disease, Dementia, Migraines, Optic Neuropathies, Brain Tumors, Hereditary Conditions (such as Leber's hereditary optic neuropathy (LHON) or retinitis pigmentosa), Epilepsy, Diplopia. Investigator discretion shall be applied to any additional conditions not listed. Eye pathologies, including but not limited to: Glaucoma Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome) Keratoconus Diabetic neuropathy/retinopathy Cytomegalovirus retinitis Diabetic macular edema (evidence of fluid) Retinitis pigmentosa Amblyopia (best corrected visual acuity [BCVA] ≥ 20/30) Chronic or acute uveitis (cells and/or flare in the anterior chamber) Strabismus (manifest/latent, exotropia, esotropia, hypertropia, exophoria, and esophoria) Abnormal astigmatism (mild to severe, > 4D) Binocular vision anomalies Chronic dry eye Monovision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Phoropter

    VisionCheck

    Arm Description

    Refraction performed by an eye care professional using a phoropter.

    Self-administered refraction performed using the EyeQue VisionCheck device.

    Outcomes

    Primary Outcome Measures

    Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.
    Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter
    Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.
    Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck

    Secondary Outcome Measures

    Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.
    95% upper prediction limit of improvement in visual acuity from refraction measurements obtained from VisionCheck compared to best corrected visual acuity from the subjective phoropter
    Assess the safety of the VisionCheck device.
    Adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), anticipated and unanticipated serious adverse device effects (ASADEs and USADEs, respectively)

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 6, 2023
    Sponsor
    EyeQue Corp.
    Collaborators
    The Emmes Company, LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06044688
    Brief Title
    EyeQue VisionCheck 510(k) Clinical Trial
    Official Title
    EyeQue VisionCheck 510(k) Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EyeQue Corp.
    Collaborators
    The Emmes Company, LLC

    4. Oversight

    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.
    No

    5. Study Description

    Brief Summary
    Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.
    Detailed Description
    The primary purpose of this study is to attain scientific objective evidence to support the VisionCheck Indications for Use by demonstrating that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. The Indications for Use are: "The EyeQue VisionCheck automated subjective refraction system provides an estimate of sphere, cylinder, and axis measurements of the eye" Furthermore, the purpose of this study is to attain scientific objective evidence regarding the precision of the VisionCheck device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Errors, Astigmatism
    Keywords
    Myopia, Hyperopia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Clinical site staff are masked to VisionCheck results. Participants are masked to VisionCheck and phoropter refraction measurements. The eyecare professionals performing Visit 2 refraction readings are masked to Visit 1 screening refraction readings.
    Allocation
    Randomized
    Enrollment
    156 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Phoropter
    Arm Type
    Experimental
    Arm Description
    Refraction performed by an eye care professional using a phoropter.
    Arm Title
    VisionCheck
    Arm Type
    Active Comparator
    Arm Description
    Self-administered refraction performed using the EyeQue VisionCheck device.
    Intervention Type
    Device
    Intervention Name(s)
    EyeQue VisionCheck
    Intervention Description
    Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.
    Intervention Type
    Device
    Intervention Name(s)
    Phoropter
    Intervention Description
    Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.
    Primary Outcome Measure Information:
    Title
    Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.
    Description
    Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter
    Time Frame
    3 months
    Title
    Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.
    Description
    Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.
    Description
    95% upper prediction limit of improvement in visual acuity from refraction measurements obtained from VisionCheck compared to best corrected visual acuity from the subjective phoropter
    Time Frame
    3 months
    Title
    Assess the safety of the VisionCheck device.
    Description
    Adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), anticipated and unanticipated serious adverse device effects (ASADEs and USADEs, respectively)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Each participant must meet the following criteria to be enrolled in this study: Participant or legally authorized representative (LAR) is willing and able to give informed consent Participant is willing and able to follow all study procedures and requirements Participant is able to use a smartphone Participant is interested in getting refraction correction measurement Participant is able to speak, read and write English fluently Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: Spherical correction >+8D or <-10D (outside the range of the VisionCheck measurement) Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement) Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement) Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect vision within the greater of three days or five half-lives prior to enrolling in this study Using an investigational drug or approved therapy for investigational use within the greater of three days or five half-lives prior to enrolling in this study Color deficiency (Ishihara pseudoisochromatic plates: Concise 14-plate edition: six or more errors on plates 1-11; the 24-plate edition: seven or more errors on plates 1-15; the 38-plate edition: nine or more errors on plates 1-21) Neurological and developmental conditions that may affect the outcome of the trial including, but not limited to, Multiple Sclerosis (MS), Stroke, Traumatic Brain Injury (TBI), Parkinson's Disease, Alzheimer's Disease, Dementia, Migraines, Optic Neuropathies, Brain Tumors, Hereditary Conditions (such as Leber's hereditary optic neuropathy (LHON) or retinitis pigmentosa), Epilepsy, Diplopia. Investigator discretion shall be applied to any additional conditions not listed. Eye pathologies, including but not limited to: Glaucoma Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome) Keratoconus Diabetic neuropathy/retinopathy Cytomegalovirus retinitis Diabetic macular edema (evidence of fluid) Retinitis pigmentosa Amblyopia (best corrected visual acuity [BCVA] ≥ 20/30) Chronic or acute uveitis (cells and/or flare in the anterior chamber) Strabismus (manifest/latent, exotropia, esotropia, hypertropia, exophoria, and esophoria) Abnormal astigmatism (mild to severe, > 4D) Binocular vision anomalies Chronic dry eye Monovision
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noam Sapiens, PhD
    Phone
    510-455-8168
    Email
    noam.sapiens@eyeque.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    EyeQue VisionCheck 510(k) Clinical Trial

    We'll reach out to this number within 24 hrs