Visual AcuityNCT04474041
Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus a Standard Eyechart.
A study testing EyeQue Insight in people with Visual Acuity, run by EyeQue Corp. at 1 site in United States.
Trial summary
Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- EyeQue Insight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2020to 24 Dec 2020
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or Female
- Ages =>7 y.o.
- Subjects that are minors (<18 years old) must have a parent or legal guardian.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Who cannot join
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks
- Medications:
- Taking medications that may affect ability to follow instructions.
- Eye Disease:
- Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.
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- Subjects that:
- Lack physical dexterity to properly operate the EyeQue App on the smartphone
- Lack the ability to follow instruction
- Lack binocular vision
- Lack the ability to maintain both eyes open
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.
Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.
Read the detailed description
The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.
- Conditions
- Visual Acuity
- Being tested
- EyeQue Insight
- Keywords
- visual acuity, screening, vision, eye care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeQue InsightDevice
The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.
| Study group | Role | What they receive |
|---|---|---|
| Visual Acuity with a Hand-held Device Supported by Mobile App. | Experimental | The Insight will be compared to a standard ETDRS eyechart Receives: Device: EyeQue Insight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acuity Visit 1
Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1.
Measured: Visit 1: Day 0
Secondary outcomes (1)
Acuity Visit 1 and 2
Variance of the best-corrected VA (BCVA) of each participant's OD, OS, and OU measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1 and Visit 2.
Measured: Visit 1 (Day 0) and Visit 2 (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start3 Jul 2020
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eye Boutique Optometry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474041
- Sponsor's protocol ID
- EYEQUE - 006
- Status last verified
- Mar 2021
- First submitted
- 1 Jul 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.
- ClinicalTrials.gov ID
- NCT04474041
- Acronym / sponsor ID
- EYEQUE - 006
- Conditions
- Visual Acuity
- Keywords
- visual acuity, screening, vision, eye care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Collaborators
- Eye Boutique Optometry
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 16 Jul 2020 (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.
Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.
Detailed description
The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Acuity with a Hand-held Device Supported by Mobile App. | Experimental | Device: EyeQue InsightThe Insight will be compared to a standard ETDRS eyechart |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- Ages =>7 y.o.
- Subjects that are minors (<18 years old) must have a parent or legal guardian.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
Key exclusion criteria (11 listed)
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks
- Medications:
- Eye Disease:
- Subjects that:
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 |
|---|---|---|
| EyeQue InsightThe Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart. | Device | Visual Acuity with a Hand-held Device Supported by Mobile App. |
Primary outcome
Acuity Visit 1
Time frame: Visit 1: Day 0
Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1.
1 secondary outcome
Acuity Visit 1 and 2
Time frame: Visit 1 (Day 0) and Visit 2 (Day 7)
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 24 Mar 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeQue Insight in people with Visual Acuity, run by EyeQue Corp. at 1 site 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 6 inclusion and 11 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Acuity Visit 1 (time frame: Visit 1: Day 0). 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 24 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.