Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
1 other identifier
interventional
358
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 22, 2021
CompletedFirst Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2021
CompletedNovember 4, 2024
October 1, 2024
2 months
August 17, 2021
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Effectiveness
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
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 Outcomes (2)
Effectiveness
Up to 3 hours
Reproducibility
Up to 3 hours
Study Arms (2)
Visibly Digital Acuity Product
EXPERIMENTALETDRS Visual Acuity Lane Test
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. Have any of the following conditions (based on subject report):
- Advanced eye disease in either eye;
- Poor vision as a result of refractive surgery in either eye;
- Unable to walk;
- Unable to hear or follow audio instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Visiblylead
Study Sites (3)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
Core, Inc
Shelby, North Carolina, 28150, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2021
First Posted
August 30, 2021
Study Start
July 22, 2021
Primary Completion
October 4, 2021
Study Completion
October 4, 2021
Last Updated
November 4, 2024
Record last verified: 2024-10