Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
NCT ID: NCT05026658
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
358 participants
INTERVENTIONAL
2021-07-22
2021-10-04
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Visibly Digital Acuity Product
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.
ETDRS Visual Acuity Lane Test
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
22 Years
40 Years
ALL
Yes
Sponsors
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Visibly
INDUSTRY
Responsible Party
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Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Core, Inc
Shelby, North Carolina, United States
Total Eye Care
Memphis, Tennessee, United States
Countries
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Other Identifiers
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VDAP-1002
Identifier Type: -
Identifier Source: org_study_id
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