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

EyeQue Corp.89 enrolled

Overview

Open label exploratory study of the EyeQue Insight in healthy volunteers \>=7 years of age.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Visual Acuity

Interventions

EyeQue InsightDEVICE

The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.

Eligibility

Sex: ALLMin age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or Female 2. Ages =\>7 y.o. 3. Subjects that are minors (\<18 years old) must have a parent or legal guardian. 4. Binocular vision 5. Willing and able to give informed consent and follow all study procedures and requirements 6. Fluent in English Exclusion Criteria: 1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19. 2. Has traveled outside the country within the last 4 weeks 3. Medications: a. Taking medications that may affect ability to follow instructions. 4. Eye Disease: a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection. 5. Subjects that: 1. Lack physical dexterity to properly operate the EyeQue App on the smartphone 2. Lack the ability to follow instruction 3. Lack binocular vision 4. Lack the ability to maintain both eyes open

Locations (1)

EyeQue

Newark, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Visit 1: Day 0

Secondary Outcomes

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.

Time frame: Visit 1 (Day 0) and Visit 2 (Day 7)

Data from ClinicalTrials.gov

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