Clincosm LogoSign in Get a demo

Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

Sponsor
Visibly (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05026658
Collaborator
(none)
358
Enrollment
3
Locations
2
Arms
2.3
Anticipated Duration (Months)
119.3
Patients Per Site
51.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Visibly Digital Acuity Product
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
358 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
Actual Study Start Date :
Jul 22, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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: V1, E, V2 E, V1, V2 V2, E, V1 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: V1, E, V2 E, V1, V2 V2, E, V1 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    2. 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

    Secondary Outcome Measures

    1. 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)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andover Eye Associates Andover Massachusetts United States 01810
    2 Core, Inc Shelby North Carolina United States 28150
    3 Total Eye Care Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Visibly

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Visibly
    ClinicalTrials.gov Identifier:
    NCT05026658
    Other Study ID Numbers:
    • VDAP-1002
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Sep 20, 2021