Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Retinopathy
- Sponsor
- Oregon Health and Science University
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Structural OCT Cyst Volume
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
David Huang
Thomas Hwang, MD, Associate Professor of Ophthalmology
Oregon Health and Science University
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Structural OCT Cyst Volume
Time Frame: 1 year
Cyst volume will be measured in mm3.
PR-OCTA Measure of Non-Perfusion Areas
Time Frame: 3 years
Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.
Structural OCT Retinal Thickening Area
Time Frame: 1 year
The area of retinal thickening will be measured in mm2.
Non-PR-OCTA Retinal Neovascularization Areas
Time Frame: 1 year
Retinal neovascularization areas will be measured in mm2.
Non-PR-OCTA Measure of Retinal Non-Perfusion Areas
Time Frame: 1 year
Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.