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Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: PDR | This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR. | ||
| Group B: NPDR | This group will consist of 60 subjects with severe non-proliferative diabetic retinopathy (NPDR), 60 subjects with moderate NPDR, and 60 subjects with mild NPDR. | ||
| Group ME: Macular Edema | This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment. | ||
| Group C: DM without Retinopathy | This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy. | ||
| Group D: Healthy Controls | This group will consist of 50 subjects with healthy eyes who do not have diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| PR-OCTA Measure of Non-Perfusion Areas | Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2. | 3 years |
| Non-PR-OCTA Measure of Retinal Non-Perfusion Areas | Non-perfusion areas of the 3 retinal plexuses will be measured in mm2. | 1 year |
| Non-PR-OCTA Retinal Neovascularization Areas | Retinal neovascularization areas will be measured in mm2. | 1 year |
| Structural OCT Cyst Volume | Cyst volume will be measured in mm3. | 1 year |
| Structural OCT Retinal Thickening Area | The area of retinal thickening will be measured in mm2. | 1 year |
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Participant-Related Inclusion Criteria:
I. All Diabetics (Groups A, B, C)
Participant-Related Exclusion Criteria:
I. Group B
Eye-Related Inclusion Criteria:
I. Group A:
II. Group B:
III. Groups C & D:
IV. Group ME:
Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)
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Adults age 18 or older with either healthy eyes or diabetic retinopathy
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hwang, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |