Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01834196

Acronym

SWEPT

Enrollment

Registered

2013-04-17

Start date

2012-08-31

Completion date

2012-11-30

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vascular Disease

Keywords

retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT

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.

Interventions

DEVICESwept-Source Optical Coherence Tomography

Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026