Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

Not Applicable

Completed

• Conditions: Digital Acuity Product
• Interventions: Device: Visibly Digital Acuity Product

• Registration Number: NCT05026658
• Lead Sponsor: Visibly

Brief Summary

Visual acuity is the relative ability of the eye to resolve detail that is usually expressed as the reciprocal of the minimum angular separation in minutes of two lines just resolvable as separate and that forms in the average human eye an angle of one minute.

Visibly Inc. has developed a method for determining a patient's visual acuity electronically via a web-based software system that can be self-administered wherever convenient. This method provides an efficient alternative for people to have immediate access to visual acuity measurements.

Detailed Description

The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, at home, to evaluate visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:

* A computer screen (the Display) which displays optotypes

* A touchscreen mobile device (the Remote) which operates as a remote control and interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away

The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's visual acuity into one of two buckets:

* 20/25 or better

* Worse than 20/25

Study Timeline

• Study Start: 2021-07-22
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• 1. Be between 22 and 40 years (inclusive) of age at the time of consent 2. Be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures

Exclusion Criteria

• 1. Have any of the following conditions (based on subject report):

  2. Advanced eye disease in either eye;

  3. Poor vision as a result of refractive surgery in either eye;

  4. Unable to walk;

  5. Unable to hear or follow audio instructions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visibly Digital Acuity Product	Visibly Digital Acuity Product	-
ETDRS Visual Acuity Lane Test	Visibly Digital Acuity Product	-

Primary Outcome Measures

Name	Time	Method
Reproducibility	Up to 3 hours	The proportion of study eyes which receive the same VA classification (20/25 or Better vs. Worse than 20/25) for the two VDAP tests
Effectiveness	Up to 3 hours	The proportion of study eyes with VDAP VA of 20/25 or better 20/25 or better \[Positive Predictive Value (PPV)\]

Secondary Outcome Measures

Name	Time	Method
Reproducibility	Up to 3 hours	The proportion of subjects with matching VDAP VA classifications (20/25 or Better vs. Worse than 20/25) for the two VDAP tests for both eyes (study eye and non-study eye)
Effectiveness	Up to 3 hours	The proportion of subjects with matching VDAP and ETDRS VA classifications (20/25 or Better vs. Worse than 20/25) for both eyes (study eye and non-study eye)

Trial Locations

Locations (3)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Core, Inc; 🇺🇸 Shelby, North Carolina, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States