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

EyeQue

Status: Completed

Conditions: Visual Acuity

Treatments: Device: EyeQue Insight

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04474041

EYEQUE - 006

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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89 participants in 1 patient group

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

Experimental group

Description:

The Insight will be compared to a standard ETDRS eyechart

Treatment:

Device: EyeQue Insight