Clinical Trial: OCT Biomarkers for Diabetic Retinopathy
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Functional Optical Coherence Tomography-Derived Biomarkers for 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.
Detailed Summary:
Sponsor: Oregon Health and Science University
Current Primary Outcome:
- Number of participants with decreased total retinal blood flow by OCT angiography [ Time Frame: 1 year ]
- Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography [ Time Frame: 1 year ]
- Number of participants with measureable macular edema by OCT imaging [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Oregon Health and Science University
Dates:
Date Received: December 30, 2014
Date Started: September 2014
Date Completion: January 2017
Last Updated: December 30, 2014
Last Verified: December 2014
