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

• Sponsor: EyeQue Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04474041
• Collaborator: Eye Boutique Optometry (Other)
• Enrollment: 89
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: EyeQue Insight	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.
• Actual Study Start Date: Jul 3, 2020
• Actual Primary Completion Date: Dec 24, 2020
• Actual Study Completion Date: Dec 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visual Acuity with a Hand-held Device Supported by Mobile App. The Insight will be compared to a standard ETDRS eyechart	Device: EyeQue Insight; The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.

Outcome Measures

Primary Outcome Measures

1. Acuity Visit 1 [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 Outcome Measures

1. Acuity Visit 1 and 2 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. Taking medications that may affect ability to follow instructions.

1. Eye Disease:

1. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.

1. Subjects that:

2. Lack physical dexterity to properly operate the EyeQue App on the smartphone

3. Lack the ability to follow instruction

4. Lack binocular vision

5. Lack the ability to maintain both eyes open

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EyeQue	Newark	California	United States	94560

Sponsors and Collaborators

• EyeQue Corp.
• Eye Boutique Optometry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EyeQue Corp.
• ClinicalTrials.gov Identifier: NCT04474041
• Other Study ID Numbers: EYEQUE - 006
• First Posted: Jul 16, 2020
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by EyeQue Corp.: visual acuity; screening; vision; eye care

Study Results

No Results Posted as of Mar 24, 2021