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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04474041

Enrollment

Registered

2020-07-16

Start date

2020-07-03

Completion date

2020-12-24

Last updated

2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

Keywords

visual acuity, screening, vision, eye care

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.

Interventions

DEVICEEyeQue Insight

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Acuity Visit 1	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.

Secondary

Measure	Time frame	Description
Acuity Visit 1 and 2	Visit 1 (Day 0) and Visit 2 (Day 7)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026