Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Not Applicable

Terminated

• Conditions: Retinal Vascular Disease
• Interventions: Device: Swept-Source Optical Coherence Tomography

• Registration Number: NCT01834196
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Status Verified: 2015-02
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Capable and willing to provide consent
2. 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
3. At least 18 years of age

Exclusion Criteria

1. Unable or unwilling to give consent
2. Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
retinal vascular occlusion arm	Swept-Source Optical Coherence Tomography	Patients with existing retinal microvascular disease will undergo imaging.

Primary Outcome Measures

Name	Time	Method
OCT images and metrics derived from the OCT images	Day of imaging, approximately 1 hour	Distributions, means, and standard deviations will be reported.

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States