MyopiaMIRABILENCT04140877
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
A study testing Visu in people with Myopia, run by Visu, Inc..
Trial summary
This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Visu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jan 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 13 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Visual Acuity of +0.20 logMAR or better in each eye;
- Is willing and able to follow instructions and maintain the appointment schedule.
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has any known active ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is amblyopic in either eye;
- Has a colour vision abnormality;
- Commonly experiences motion sickness.
About this study
This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.
- Conditions
- Myopia
- Being tested
- Visu
- Keywords
- Choroidal thickness, Virtual reality
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuDevice
An experimental (test) virtual reality display
| Study group | Role | What they receive |
|---|---|---|
| Visu OD, Control OS | Other | Contralateral eye study Receives: Device: Visu |
| Control OD, Visu OS | Other | Contralateral eye study Receives: Device: Visu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Measured: 2 hours
Secondary outcomes (2)
Choroidal thickness
Measured: 3 months
Axial length
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Strategy change
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, contralateral eye study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visu, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FCOptom, Principal investigator, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140877
- Sponsor's protocol ID
- P/689/19/VU
- Acronym
- MIRABILE
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
- ClinicalTrials.gov ID
- NCT04140877
- Acronym / sponsor ID
- MIRABILE / P/689/19/VU
- Conditions
- Myopia
- Keywords
- Choroidal thickness, Virtual reality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategy change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Visu, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 28 Oct 2019 (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.
This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, contralateral eye study
| Arm | Type | Receives |
|---|---|---|
| Visu OD, Control OS | Other | Device: VisuContralateral eye study |
| Control OD, Visu OS | Other | Device: VisuContralateral eye study |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 13 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Visual Acuity of +0.20 logMAR or better in each eye;
- Is willing and able to follow instructions and maintain the appointment schedule.
Key exclusion criteria (6 listed)
- Is participating in any concurrent clinical or research study;
- Has any known active ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is amblyopic in either eye;
- Has a colour vision abnormality;
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 |
|---|---|---|
| VisuAn experimental (test) virtual reality display | Device | Control OD, Visu OS, Visu OD, Control OS |
Primary outcome
Choroidal thickness
Time frame: 2 hours
2 secondary outcomes
Choroidal thickness
Time frame: 3 months
Axial length
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
Lyndon Jones, PhD, FCOptom principal investigator
Centre for Ocular Research and Education
Questions about this trial
What is this clinical trial studying?
A study testing Visu in people with Myopia, run by Visu, Inc..
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Choroidal thickness (time frame: 2 hours). 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 Jun 2020.