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OpenTrials
Completed

NCT Number: NCT04474041

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

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

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Key information

Conditions

Visual Acuity

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EyeQue

Newark, California, 94560, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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-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

Treatment and study plan

EyeQue Insight

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acuity Visit 1 and 2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EyeQue Corp.

Industry

Collaborators

  • Eye Boutique Optometry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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