Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

September 17, 2021 updated by: Visibly

A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Recruiting
        • Andover Eye Associates
        • Contact:
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Core, Inc
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Total Eye Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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):

    1. Advanced eye disease in either eye;
    2. Poor vision as a result of refractive surgery in either eye;
    3. Unable to walk;
    4. Unable to hear or follow audio instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visibly Digital Acuity Product
Device: Visibly Digital Acuity Product

The order of testing (two VDAP home environments and ETDRS) will be randomly assigned for each subject as one of four sequences:

  1. V1, E, V2
  2. E, V1, V2
  3. V2, E, V1
  4. E, V2, V1

Where E denotes the ETDRS assessment, V1 denotes the VDAP assessment in home environment 1, and V2 denotes the VDAP assessment in home environment 2.

The randomization will be blocked in groups of 4 subjects to ensure balance for the VA testing sequences.

Other Names:
  • ETDRS Chart
Experimental: ETDRS Visual Acuity Lane Test
Device: Visibly Digital Acuity Product

The order of testing (two VDAP home environments and ETDRS) will be randomly assigned for each subject as one of four sequences:

  1. V1, E, V2
  2. E, V1, V2
  3. V2, E, V1
  4. E, V2, V1

Where E denotes the ETDRS assessment, V1 denotes the VDAP assessment in home environment 1, and V2 denotes the VDAP assessment in home environment 2.

The randomization will be blocked in groups of 4 subjects to ensure balance for the VA testing sequences.

Other Names:
  • ETDRS Chart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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)]
Up to 3 hours
Reproducibility
Time Frame: 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
Up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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)
Up to 3 hours
Reproducibility
Time Frame: 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)
Up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visibly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • VDAP-1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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