This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.
This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project. Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
13
Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.
Duke Eye Center
Durham, North Carolina, United States
OCT images and metrics derived from the OCT images
Distributions, means, and standard deviations will be reported.
Time frame: Day of imaging, approximately 1 hour
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