Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Retinal Vascular Disease Clinical Trial

— SWEPT  

Official title:

Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01834196
• Other study ID #: Pro00038240
• Status: Terminated
• Phase: N/A
• First received: April 15, 2013
• Last updated: March 20, 2017
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Vascular Disease
• Vascular Diseases

Intervention

Device:
• Swept-Source Optical Coherence Tomography
Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT images and metrics derived from the OCT images	Distributions, means, and standard deviations will be reported.	Day of imaging, approximately 1 hour