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Clinical Trials/NCT01834196
NCT01834196
Terminated
Not Applicable

Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Duke University1 site in 1 country13 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retinal Vascular Disease
Sponsor
Duke University
Enrollment
13
Locations
1
Primary Endpoint
OCT images and metrics derived from the OCT images
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Capable and willing to provide consent
  • history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
  • At least 18 years of age

Exclusion Criteria

  • Unable or unwilling to give consent
  • Under 18 years of age

Outcomes

Primary Outcomes

OCT images and metrics derived from the OCT images

Time Frame: Day of imaging, approximately 1 hour

Distributions, means, and standard deviations will be reported.

Study Sites (1)

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