Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging (PVOCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01717937|
Recruitment Status : Terminated (insufficient enrollment)
First Posted : October 31, 2012
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment|
|Age-related Macular Degeneration Diabetic Retinopathy Hypertensive Retinopathy Retinal Vein Occlusion Retinal Artery Occlusion||Procedure: Phase variance optical coherence tomography (PV-OCT)|
Fluorescein angiography (FA) has long been the gold standard for vascular imaging of the retina and choroid. It is a test that involves the intravenous injection of fluorescein dye, followed by imaging of the dye's passage through the blood vessels inside the eye. It is commonly used to diagnose many forms of retinovascular disease, as well as to assess the retina's response to various therapeutic interventions. While FA is a relatively safe diagnostic test, it carries the risk of both minor and major side effects. These include nausea and vomiting, yellowing of the skin and urine, vascular extravasation with skin eruption and necrosis, vasovagal reactions, myocardial infarction, respiratory failure, anaphylaxis, cardiopulmonary arrest, and death. Additionally, the test is time-consuming, technically difficult to perform, and requires patients to undergo the discomfort associated with intravenous access. Despite these drawbacks, FA is still commonly used in clinical practice, as there are no existing alternative tests with the ability to provide comparable detail of the retinal and choroidal vasculature.
Phase-variance optical coherence tomography is a novel, noninvasive, software-based technology capable of generating angiographic images from the data gathered by standard OCT scans. Preliminary research suggests it can produce high-definition representations of the retinal and choroidal vasculature which may be more detailed than the images produced by FA.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Subjects will receive fluorescein angiography (FA) as part of their normal clinical evaluation and will undergo phase variance optical coherence tomography (PV-OCT) as the study intervention. This involves having subjects undergo standard, noninvasive optical coherence tomography (OCT) scans with an FDA-approved OCT device, and the data gathered by this device will be transferred to a separate computer for processing using novel software. This software is capable of utilizing the existing data to generate phase variance OCT images.
Procedure: Phase variance optical coherence tomography (PV-OCT)
Subjects will undergo standard, noninvasive optical coherence tomography (OCT) scans with an FDA-approved OCT device, and the data gathered by this device will be transferred to a separate computer for processing using novel software. This software is capable of utilizing the existing data to generate phase variance OCT images. There are no known risks associated with OCT scans.
- Measurement of to be determined physical characteristics of retinovascular structures seen on phase variance optical coherence tomography (PV-OCT) and fluorescein angiography(FA). [ Time Frame: On the day in which a patient receives PV-OCT and FA imaging, estimated to take 2 hours. ]Masked examiners (retina specialists) will evaluate and grade coded PV-OCT and FA images for the presence and features of various retinovascular abnormalities (e.g., choroidal neovascular membranes, microaneurysms, venous dilation, etc.). Metrics to determined and may include: size, depth, area, volume, and relative position. Each subject's graded PV-OCT images will be compared to their graded FA images.
- Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA. [ Time Frame: Up to 12 months after enrollment. ]Each time a subject is determined to require OCT imaging as part of their normal clinical evaluation over the duration of the study, a PV-OCT scan will also be performed. Measured to be determined physical characteristics of these scans will be compared to measurements obtained from prior PV-OCT images in order to assess changes over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717937
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Scott M McClintic, M.D.||University of California, San Francisco|
|Principal Investigator:||Daniel M Schwartz, M.D.||University of California, San Francisco|