Portland, Oregon 97239


Purpose:

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.


Criteria:

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 Exclusion Criteria for participants without diabetes (controls): - 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 any eye disease 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


NCT ID:

NCT02330042


Primary Contact:

Principal Investigator
Thomas Hwang, MD
Oregon Health and Science University

David Poole, COT
Phone: 503-494-8024
Email: pooleb@ohsu.edu


Backup Contact:

Email: romfhd@ohsu.edu
Denzil Romfh, OD
Phone: 503-494-4351


Location Contact:

Portland, Oregon 97239
United States

David Poole, COT
Phone: 503-494-8024
Email: pooleb@ohsu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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