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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474041
• Other study ID #: EYEQUE - 006
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: December 24, 2020

Study information

• Verified date: March 2021
• Source: EyeQue Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
United States	EyeQue	Newark	California

Sponsors (2)

Lead Sponsor	Collaborator
EyeQue Corp.	Eye Boutique Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)