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

EyeQue Corp.1 site in 1 country89 target enrollmentJuly 3, 2020

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: EyeQue Corp.
Enrollment: 89
Locations: 1
Primary Endpoint: Acuity Visit 1
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

July 3, 2020

End Date

December 24, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

EyeQue Corp.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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

Outcomes

Primary Outcomes

Acuity Visit 1

Time Frame: Visit 1: Day 0

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.