Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus a Standard Eyechart.

Study Overview
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Brief Summary
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Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.

Detailed Description
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The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.

Official Title
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A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: EyeQue Insight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Ages =>7 y.o. Subjects that are minors (<18 years old) must have a parent or legal guardian. 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 Medications: a. Taking medications that may affect ability to follow instructions. Eye Disease: a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection. Subjects that: Lack physical dexterity to properly operate the EyeQue App on the smartphone Lack the ability to follow instruction Lack binocular vision Lack the ability to maintain both eyes open

Ages Eligible for Study
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Minimum Age: 7 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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Acuity with a Hand-held Device Supported by Mobile App.<br>The Insight will be compared to a standard ETDRS eyechart | Device: EyeQue Insight<br>* The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acuity Visit 1 | Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1. | Visit 1: Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acuity Visit 1 and 2 | Variance of the best-corrected VA (BCVA) of each participant's OD, OS, and OU measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1 and Visit 2. | Visit 1 (Day 0) and Visit 2 (Day 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual acuity, screening, vision, eye care