EyeQue VisionCheck 510(k) Clinical Trial

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

Detailed Description
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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.

Official Title
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EyeQue VisionCheck 510(k) Clinical Trial

Conditions
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Refractive Errors, Astigmatism

Intervention / Treatment
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* Device: EyeQue VisionCheck
* Device: Phoropter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Hyperopia