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

NCT04474041 | Completed FDA Device

• 1 other identifier: EYEQUE - 006
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Visual Acuity

Keywords

visual acuity; screening; vision; eye care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acuity Visit 1 and 2

  Visit 1 (Day 0) and Visit 2 (Day 7)

Study Arms (1)

Visual Acuity with a Hand-held Device Supported by Mobile App.

EXPERIMENTAL

The Insight will be compared to a standard ETDRS eyechart

Device: EyeQue Insight

Interventions

EyeQue Insight DEVICE

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

Visual Acuity with a Hand-held Device Supported by Mobile App.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeQue Corp.: lead
• Eye Boutique Optometry: collaborator

Study Sites (1)

EyeQue

Newark, California, 94560, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 16, 2020
• Study Start: July 3, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)