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| ID | Type | Description | Link |
|---|---|---|---|
| N001 | Other Identifier | Neuroptek Corporation Inc. |
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| Name | Class |
|---|---|
| St. Boniface Hospital | OTHER |
| St. Boniface Hospital Asper Clinical Research Institute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeMirage device | Device | This is a novel, smartphone-based device powered by artificial intelligence that will be used for virtual and remote routine eye examinations. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of follow-up visit at Day 30 + 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bram Ramjiawan, PhD | St. Boniface Hospital Asper Clinical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Eye Care Centre | Winnipeg | Manitoba | R2H 0S8 | Canada | ||
| Brain, Vision and Concussion Clinic |
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.
Within a year after the final study report has been generated.
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| Winnipeg |
| Manitoba |
| R2M 2X9 |
| Canada |
| Prairie Eye Care (Northgate) | Winnipeg | Manitoba | R2V 3C4 | Canada |
| Armstrong + Small Eye Care Centre | Winnipeg | Manitoba | R3G 0S7 | Canada |