EyeQue VisionCheck 510(k) Clinical Trial

Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractive Errors; Astigmatism
• Intervention / Treatment: Device: Phoropter; Device: EyeQue VisionCheck

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noam Sapiens, PhD; Phone Number: 510-455-8168; Email: noam.sapiens@eyeque.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Each participant must meet the following criteria to be enrolled in this study:

1. Participant or legally authorized representative (LAR) is willing and able to give informed consent
2. Participant is willing and able to follow all study procedures and requirements
3. Participant is able to use a smartphone
4. Participant is interested in getting refraction correction measurement
5. 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:

1. Spherical correction >+8D or <-10D (outside the range of the VisionCheck measurement)
2. Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
3. Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
4. 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
5. 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
6. Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement)
7. 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
8. 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
9. 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)
10. 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.

11. Eye pathologies, including but not limited to:

    1. Glaucoma
    2. Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema
    3. Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome)
    4. Keratoconus
    5. Diabetic neuropathy/retinopathy
    6. Cytomegalovirus retinitis
    7. Diabetic macular edema (evidence of fluid)
    8. Retinitis pigmentosa
    9. Amblyopia (best corrected visual acuity [BCVA] ≥ 20/30)
    10. Chronic or acute uveitis (cells and/or flare in the anterior chamber)
    11. Strabismus (manifest/latent, exotropia, esotropia, hypertropia, exophoria, and esophoria)
    12. Abnormal astigmatism (mild to severe, > 4D)
    13. Binocular vision anomalies
    14. Chronic dry eye
    15. Monovision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phoropter; Refraction performed by an eye care professional using a phoropter.	Device: Phoropter; Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.
Active Comparator: VisionCheck; Self-administered refraction performed using the EyeQue VisionCheck device.	Device: EyeQue VisionCheck; Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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)	3 months

Collaborators and Investigators

• Sponsor: EyeQue Corp.
• Collaborators: The Emmes Company, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hyperopia; Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EYEQUE-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No