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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01834196
Other study ID # Pro00038240
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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