Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

• ClinicalTrials.gov Identifier: NCT05026658
• Recruitment Status: Recruiting
• First Posted: August 30, 2021
• Last Update Posted: September 20, 2021
• Sponsor: Visibly
• Information provided by (Responsible Party): Visibly

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
Digital Acuity Product	Device: Visibly Digital Acuity Product	Not Applicable

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 (Clinical Trial)
• Estimated 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: July 22, 2021
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 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 Name: 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 Name: ETDRS Chart

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)]
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

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)
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)

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Paul Foley; 217-971-4852; paul@govisibly.com

Locations

United States, Massachusetts

Andover Eye Associates; Recruiting

Andover, Massachusetts, United States, 01810

Contact: Paul Foley 217-971-4852 paul@govisibly.com

United States, North Carolina

Core, Inc; Recruiting

Shelby, North Carolina, United States, 28150

Contact: Paul Foley 217-971-4852 paul@govisibly.com

United States, Tennessee

Total Eye Care; Recruiting

Memphis, Tennessee, United States, 38119

Contact: Paul Foley 217-971-4852 paul@govisibly.com

Sponsors and Collaborators

Visibly

More Information

• Responsible Party: Visibly
• ClinicalTrials.gov Identifier: NCT05026658
• Other Study ID Numbers: VDAP-1002
• First Posted: August 30, 2021
• Last Update Posted: September 20, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes