MyopiaNCT04693260
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
A study testing Visual Acuity with a Hand-held Device Supported by Mobile App. in people with Myopia, run by EyeQue Corp. at 1 site in United States.
Trial summary
The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Visual Acuity with a Hand-held Device Supported by Mobile App.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2020to 10 Sep 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 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
- Be treated for myopia with Ortho-K, day contacts, or night contacts
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, keratoconus, etc.
Show all 12Show fewer
- 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
- Had eye surgery within the last 12 months (including Lasik)
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Boutique Optometry
Santa Clara, California, 95051
About this study
The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
Read the detailed description
A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
- Conditions
- Myopia
- Being tested
- Visual Acuity with a Hand-held Device Supported by Mobile App.
- Keywords
- myopia, Ortho-k, vision
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Acuity with a Hand-held Device Supported by Mobile App.Device
The Insight will be compared to a standard ETDRS eyechart
| Study group | Role | What they receive |
|---|---|---|
| Hand-held Device Supported by Mobile Application | Other | Insight device ETDRS measurement compared to a standard ETDRS chart Receives: Device: Visual Acuity with a Hand-held Device Supported by Mobile App. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Departure from scheduled follow-up visits with clinical confirmation
Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted.
Measured: Approximately 21 Weeks
Secondary outcomes (1)
Measure rapidly changing visual acuity
Ability to track and measure visual acuity with the EyeQue Insight in patients with rapidly changing visual acuity during the first month of Ortho-K introduction.
Measured: Approximately 21 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start3 Jul 2020
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT04693260
- Sponsor's protocol ID
- EYEQUE - 007
- Status last verified
- Aug 2022
- First submitted
- 29 Dec 2020
- Last updated
- 22 Aug 2022
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
- ClinicalTrials.gov ID
- NCT04693260
- Acronym / sponsor ID
- EYEQUE - 007
- Conditions
- Myopia
- Keywords
- myopia, Ortho-k, vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Collaborators
- Eye Boutique Optometry
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 5 Jan 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.
The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
Detailed description
A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand-held Device Supported by Mobile Application | Other | Device: Visual Acuity with a Hand-held Device Supported by Mobile App.Insight device ETDRS measurement compared to a standard ETDRS chart |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 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 (12 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 |
|---|---|---|
| Visual Acuity with a Hand-held Device Supported by Mobile App.The Insight will be compared to a standard ETDRS eyechart | Device | Hand-held Device Supported by Mobile Application |
Primary outcome
Departure from scheduled follow-up visits with clinical confirmation
Time frame: Approximately 21 Weeks
Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted.
1 secondary outcome
Measure rapidly changing visual acuity
Time frame: Approximately 21 Weeks
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 22 Aug 2022.
- 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 Visual Acuity with a Hand-held Device Supported by Mobile App. in people with Myopia, 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 7 inclusion and 12 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 22 Aug 2022. 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?
Departure from scheduled follow-up visits with clinical confirmation (time frame: Approximately 21 Weeks). 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 22 Aug 2022.