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History of Changes for Study: NCT05026658
Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
Latest version (submitted September 17, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 23, 2021 None (earliest Version on record)
2 September 17, 2021 Study Design and Study Status
Comparison Format:

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Study NCT05026658
Submitted Date:  September 17, 2021 (v2)

Open or close this module Study Identification
Unique Protocol ID: VDAP-1002 VDAP-1002
Brief Title: Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
Official Title: A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2021 August 2021
Overall Status: RecruitingRecruiting
Study Start: July 22, 2021 July 22, 2021
Primary Completion: September 30, 2021 [Anticipated] September 30, 2021 [Anticipated]
Study Completion: September 30, 2021 [Anticipated] September 30, 2021 [Anticipated]
First Submitted: August 17, 2021 August 17, 2021
First Submitted that
Met QC Criteria:
August 23, 2021 August 23, 2021
First Posted: August 30, 2021 [Actual] August 30, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
September 17, 2021 September 17, 2021
Last Update Posted: September 20, 2021 [Actual] September 20, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Visibly Visibly
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: YesYes
Unapproved/Uncleared Device: YesYes
Pediatric Postmarket Surveillance:
Data Monitoring:
Open or close this module 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.

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

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
Open or close this module Conditions
Conditions: Digital Acuity Product Digital Acuity Product
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: OtherOther
Study Phase: Not ApplicableNot Applicable
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: None (Open Label)None (Open Label)
Allocation: RandomizedRandomized
Enrollment: 358 [Anticipated] 358 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)]
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)]
2. 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
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
Secondary Outcome Measures:
1. 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)
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)
2. 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)
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)
Open or close this module Eligibility
Minimum Age: 22 Years 22 Years
Maximum Age: 40 Years 40 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
Criteria:

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.

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.
Open or close this module Contacts/Locations
Central Contact Person: Paul Foley
Telephone: 217-971-4852
Email: paul@govisibly.com
Paul Foley
Telephone: 217-971-4852
Email: paul@govisibly.com
Locations: United States, MassachusettsUnited States, Massachusetts
Andover Eye Associates
[Recruiting]
Andover, Massachusetts, United States, 01810
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
Andover Eye Associates
[Recruiting]
Andover, Massachusetts, United States, 01810
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
United States, North CarolinaUnited States, North Carolina
Core, Inc
[Recruiting]
Shelby, North Carolina, United States, 28150
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
Core, Inc
[Recruiting]
Shelby, North Carolina, United States, 28150
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
United States, TennesseeUnited States, Tennessee
Total Eye Care
[Recruiting]
Memphis, Tennessee, United States, 38119
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
Total Eye Care
[Recruiting]
Memphis, Tennessee, United States, 38119
Contact:Contact: Paul Foley 217-971-4852 paul@govisibly.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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