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

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Duke University

Status

Terminated

Conditions

Retinal Vascular Disease

Treatments

Device: Swept-Source Optical Coherence Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01834196
Pro00038240

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

retinal vascular occlusion arm
Other group
Description:
Patients with existing retinal microvascular disease will undergo imaging.
Treatment:
Device: Swept-Source Optical Coherence Tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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