Visual FunctionNCT06908967
A Performance Study Comparing the EyeMirage (Test Device) to Standard of Care (Reference Device) in Patients 18 to 65 Years of Age Undergoing Standard Eye Examinations Such as Visual Acuity, Visual Field, Color Vision, and Self-Paced Saccade for Various Conditions
A study testing EyeMirage device in people with Visual Function, run by Neuroptek Corporation Inc. at 4 sites in Canada.
Trial summary
This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics and that of this new device. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Function
- What is being tested?
- EyeMirage device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesCanada
- Study dates
- 13 Jun 2025to 24 Feb 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of a signed and dated informed consent document confirming that the participant has been informed of all aspects of the clinical study.
- Male or female participants, 18 to 65 years of age at time of screening.
- Visual acuity of 20/200 or better.
- Willingness to comply with required screening procedures, eye assessments, and follow-up visits, if needed.
Who cannot join
- Visual acuity worse than 20/200 in either eye
- Complete blindness or diffuse vision loss in either eye
- Clinical diagnosis of cognitive and motor diseases including but not limited to the following:
- Neurodegenerative diseases such as dementia-like Alzheimer's disease, posterior cortical atrophy
- Movement disorders such as Parkinson's disease and Parkinsonism tremors
- Multiple sclerosis, stroke or any other neurological or physical conditions with paresis or plegia (i.e. weakness or paralysis of the limbs)
- Eyes with a spherical equivalent of greater than +9 or -9 diopters where the corrective lens is too large to fit in the headset.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St. Boniface Eye Care Centre
Winnipeg, Manitoba, R2H 0S8
Brain, Vision and Concussion Clinic
Winnipeg, Manitoba, R2M 2X9
Prairie Eye Care (Northgate)
Winnipeg, Manitoba, R2V 3C4
Armstrong + Small Eye Care Centre
Winnipeg, Manitoba, R3G 0S7
About this study
Official title: An Open-label, Single-blinded, Randomized, 2-way Crossover, Performance Study of the EyeMirage (Test Device) Relative to Standard of Care (Reference Device) in Patients Undergoing Standard Eye Examinations for Various Conditions
This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics and that of this new device. Participants of this study will undergo the four eye tests using both the new device and the standard of care devices.
The study will be done in one visit to the eye clinic. Thirty days after the eye tests were done, participants will be called by the clinic for a general follow-up and to discuss any problems, if needed.
- Conditions
- Visual Function
- Being tested
- EyeMirage device
- Keywords
- visual function, visual acuity, visual field, color vision, self-paced saccade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeMirage deviceDevice
This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the current standard of care tests and then using the EyeMirage device and app. Receives: Device: EyeMirage device |
| EyeMirage | Other | This Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the EyeMirage device and app, then via the standard of care tests. Receives: Device: EyeMirage device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care
Results of the eye assessments for visual acuity, visual field, color vision, and self-paced saccade using the EyeMirage device and app, and standard of care will be analyzed using the paired t-test. Insignificant p values (>0.5) will indicate that there is no statistical difference between eye assessment results from the use of EyeMirage compared to those obtained from current standard of care clinical testing.
Measured: From enrollment to the end of follow-up visit at Day 30 + 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start13 Jun 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FunctionStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroptek Corporation Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital, St. Boniface Hospital Asper Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Bram Ramjiawan, PhD, Study director, St. Boniface Hospital Asper Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908967
- Sponsor's protocol ID
- HS26606 (B2024:096)
- Other IDs
- N001
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data gathered from the use of the device as compared to standard of care in testing for visual acuity, visual field, color vision, and self-paced saccade will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-blinded, Randomized, 2-way Crossover, Performance Study of the EyeMirage (Test Device) Relative to Standard of Care (Reference Device) in Patients Undergoing Standard Eye Examinations for Various Conditions
- ClinicalTrials.gov ID
- NCT06908967
- Acronym / sponsor ID
- HS26606 (B2024:096)
- Conditions
- Visual Function
- Keywords
- visual function, visual acuity, visual field, color vision, self-paced saccade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Neuroptek Corporation Inc.University, hospital or other
- Collaborators
- St. Boniface Hospital, St. Boniface Hospital Asper Clinical Research Institute
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 3 Apr 2025 (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 study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics and that of this new device. Participants of this study will undergo the four eye tests using both the new device and the standard of care devices.
The study will be done in one visit to the eye clinic. Thirty days after the eye tests were done, participants will be called by the clinic for a general follow-up and to discuss any problems, if needed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Device: EyeMirage deviceThis Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the current standard of care tests and then using the EyeMirage device and app. |
| EyeMirage | Other | Device: EyeMirage deviceThis Cohort will undergo assessments for visual acuity, visual field, color vision, and self-paced saccade first via the EyeMirage device and app, then via the standard of care tests. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Evidence of a signed and dated informed consent document confirming that the participant has been informed of all aspects of the clinical study.
- Male or female participants, 18 to 65 years of age at time of screening.
- Visual acuity of 20/200 or better.
- Willingness to comply with required screening procedures, eye assessments, and follow-up visits, if needed.
Key exclusion criteria (7 listed)
- Visual acuity worse than 20/200 in either eye
- Complete blindness or diffuse vision loss in either eye
- Clinical diagnosis of cognitive and motor diseases including but not limited to the following:
- Eyes with a spherical equivalent of greater than +9 or -9 diopters where the corrective lens is too large to fit in the headset.
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 |
|---|---|---|
| EyeMirage deviceThis is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations. | Device | EyeMirage, Standard of Care |
Primary outcome
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care
Time frame: From enrollment to the end of follow-up visit at Day 30 + 7 days
Results of the eye assessments for visual acuity, visual field, color vision, and self-paced saccade using the EyeMirage device and app, and standard of care will be analyzed using the paired t-test. Insignificant p values (>0.5) will indicate that there is no statistical difference between eye assessment results from the use of EyeMirage compared to those obtained from current standard of care clinical testing.
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 12 Mar 2026.
- Individual participant dataSharing planned: Yes. Data gathered from the use of the device as compared to standard of care in testing for visual acuity, visual field, color vision, and self-paced saccade will be shared.
Related trials for Visual Function
RecruitingObservational study
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4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Not yet recruiting
joyVision: The Superiority of Co-design in the Development of a Serious Game for Children With Cerebral Visual Impairment
Cerebral Visual Impairment
RecruitingPhase 1
A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People
Healthy Volunteers
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
Ocular Graft Versus Host Disease
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.
Bram Ramjiawan, PhD study director
St. Boniface Hospital Asper Clinical Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeMirage device in people with Visual Function, run by Neuroptek Corporation Inc. at 4 sites in Canada.
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 7 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Accuracy and Reliability of EyeMirage Test Results from Four Elements of Visual Testing in Comparison to Current Standard of Care (time frame: From enrollment to the end of follow-up visit at Day 30 + 7 days). 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 12 Mar 2026.