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Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinal Imaging using the OSNAT800 IO device | Experimental | Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSNAT 800 IO | Device | Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful performance of the real-time eye tracking function by post-image processing | Successful acquisition of retinal images | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device usability as assessed by a survey | Qualitative assessment of user feedback | Through study completion, an average of 6 months |
| Image Quality as assessed by user assessment of image quality parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Retina Consultants | Edmonton | Canada |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Qualitative assessment of image at time of acquisition
| Through study completion, an average of 6 months |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |