Digital Acuity ProductNCT05026658
Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study
A study testing Visibly Digital Acuity Product in people with Digital Acuity Product, run by Visibly at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Acuity Product
- What is being tested?
- Visibly Digital Acuity Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jul 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 1. 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Total Eye Care
Memphis, Tennessee, 38119
Core, Inc
Shelby, North Carolina, 28150
About this study
Official title: A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
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.
Read the 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
- Conditions
- Digital Acuity Product
- Being tested
- Visibly Digital Acuity Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visibly Digital Acuity ProductDevice
Also called ETDRS Chart
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.
| Study group | Role | What they receive |
|---|---|---|
| Visibly Digital Acuity Product | Experimental | Not described Receives: Device: Visibly Digital Acuity Product |
| ETDRS Visual Acuity Lane Test | Experimental | Not described Receives: Device: Visibly Digital Acuity Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The proportion of study eyes with VDAP VA of 20/25 or better 20/25 or better [Positive Predictive Value (PPV)]
Measured: 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
Measured: Up to 3 hours
Secondary outcomes (2)
Effectiveness
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)
Measured: Up to 3 hours
Reproducibility
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)
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start22 Jul 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Acuity ProductStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visibly
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026658
- Sponsor's protocol ID
- VDAP-1002
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product
- ClinicalTrials.gov ID
- NCT05026658
- Acronym / sponsor ID
- VDAP-1002
- Conditions
- Digital Acuity Product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- VisiblyIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visibly Digital Acuity Product | Experimental | Device: Visibly Digital Acuity Product |
| ETDRS Visual Acuity Lane Test | Experimental | Device: Visibly Digital Acuity Product |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 1. Have any of the following conditions (based on subject report):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visibly Digital Acuity ProductAlso: ETDRS ChartThe 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. | Device | ETDRS Visual Acuity Lane Test, Visibly Digital Acuity Product |
Primary outcome
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)]
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
2 secondary outcomes
Effectiveness
Time frame: Up to 3 hours
Reproducibility
Time frame: Up to 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visibly Digital Acuity Product in people with Digital Acuity Product, run by Visibly at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: Up to 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.