Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging (SWEPT)

March 20, 2017 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: retinal vascular occlusion arm
Patients with existing retinal microvascular disease will undergo imaging.
Device: Swept-Source Optical Coherence Tomography
Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of imaging, approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Prithu Mettu, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (ESTIMATE)

April 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00038240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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