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

NCT ID: NCT04474041

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2020-12-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Visual Acuity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

The Insight will be compared to a standard ETDRS eyechart

Group Type EXPERIMENTAL

EyeQue Insight

Intervention Type DEVICE

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

Interventions

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EyeQue Insight

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eye Boutique Optometry

UNKNOWN

Sponsor Role collaborator

EyeQue Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EyeQue

Newark, California, United States

Site Status

Countries

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United States

Other Identifiers

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EYEQUE - 006

Identifier Type: -

Identifier Source: org_study_id

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