Diabetic Retinopathy
Conditions
Keywords
Diabetes, OCT, Angiography, Diabetic retinopathy
Brief summary
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.
Interventions
None listed
Sponsors
Oregon Health and Science University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participant-Related Inclusion Criteria: I. All Diabetics (Groups A, B, C) * Type 1 diabetes of at least 5 years duration or * Type 2 diabetes of any duration II. Group B * Able to return for follow-up over 3 years Participant-Related
Exclusion criteria
I. Group B * Significant medical condition that would make long-term follow-up difficult II. Controls (Group D) * Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.) Eye-Related Inclusion Criteria: I. Group A: * Presence of active neovascularization, with or without prior treatment * Presence of involuted fibrovascular proliferans II. Group B: * NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale III. Groups C & D: * No evidence of diabetic retinopathy IV. Group ME: * Presence of center-involving macular edema requiring treatment Eye-Related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PR-OCTA Measure of Non-Perfusion Areas | 3 years | Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2. |
| Non-PR-OCTA Measure of Retinal Non-Perfusion Areas | 1 year | Non-perfusion areas of the 3 retinal plexuses will be measured in mm2. |
| Non-PR-OCTA Retinal Neovascularization Areas | 1 year | Retinal neovascularization areas will be measured in mm2. |
| Structural OCT Cyst Volume | 1 year | Cyst volume will be measured in mm3. |
| Structural OCT Retinal Thickening Area | 1 year | The area of retinal thickening will be measured in mm2. |
Countries
United States
Outcome results
None listed