Diabetic Retinopathy
Conditions
Keywords
Diabetes, OCT, Angiography, Diabetic retinopathy
Brief summary
Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.
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 79 Years
Healthy volunteers
Yes
Inclusion criteria
for participants with diabetes: * Male or female participants 18-79 years old * With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration
Exclusion criteria
for participants with diabetes: * Vision worse than 20/200 * Inability to maintain fixation for OCT imaging * Significant kidney disease, kidney failure or kidney transplant * Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease * Pregnant or nursing an infant * Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy * Significant cataract, corneal scar, vitreous bleed or other media opacity * History of major eye surgery within 4 months prior to enrollment in this study Inclusion Criteria for participants without diabetes (controls): * Male or female participants 18-79 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with decreased total retinal blood flow by OCT angiography | 1 year | Total retinal blood flow will be measured in uL/min. |
| Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography | 1 year | Neovascular membrane area will be measured in mm2. |
| Number of participants with measureable macular edema by OCT imaging | 1 year | Retinal thickening area will be measured in mm2. |
Countries
United States
Outcome results
None listed