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

Not Applicable

Completed

• Conditions: Visual Acuity
• Interventions: Device: EyeQue Insight

• Registration Number: NCT04474041
• Lead Sponsor: EyeQue Corp.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-01
• Study Start: 2020-07-03
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Primary Completion: 2020-12-24
• Study Completion: 2020-12-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Visual Acuity with a Hand-held Device Supported by Mobile App.	EyeQue Insight	The Insight will be compared to a standard ETDRS eyechart

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

EyeQue; 🇺🇸 Newark, California, United States