Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging (PVOCT)

This study is currently recruiting participants.
Verified September 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01717937
First received: October 28, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine whether phase variance optical coherence tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (FA), the current gold standard diagnostic test.


Condition Intervention
Age-related Macular Degeneration
Diabetic Retinopathy
Hypertensive Retinopathy
Retinal Vein Occlusion
Retinal Artery Occlusion
Procedure: Phase variance optical coherence tomography (PV-OCT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 78
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PVOCT
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients seen in the University of California, San Francisco Retina Clinic with suspected or established retinovascular disease and who are scheduled to undergo fluorescein angiography as part of their normal clinical evaluation.

Criteria

Inclusion Criteria:

  1. Patients with suspected or established retinovascular disease who are going to undergo FA as part of their usual clinical evaluation.
  2. Patients must be age 13 or above.
  3. Patients must be able to speak and understand the English language in order to provide informed consent.

Exclusion Criteria:

  1. Any patients who are unwilling to participate or provide informed consent.
  2. Any patients who are pregnant at the time of enrollment.
  3. Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717937

Contacts
Contact: Scott M McClintic, M.D. 415-269-3025 smcclint@gmail.com
Contact: Daniel M Schwartz, M.D. 415-710-2880 dan.schwartz@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94118
Principal Investigator: Daniel M Schwartz, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Scott M McClintic, M.D. University of California, San Francisco
Principal Investigator: Daniel M Schwartz, M.D. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01717937     History of Changes
Other Study ID Numbers: PVOCT-12-10060
Study First Received: October 28, 2012
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
retinovascular disease
imaging
fluorescein angiography
FA
angiography
optical coherence tomography
OCT
phase variance
comparison
age-related macular degeneration
diabetic retinopathy
hypertensive retinopathy
retinal vein occlusion
retinal artery occlusion

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Retinal Artery Occlusion
Retinal Diseases
Retinal Vein Occlusion
Hypertensive Retinopathy
Arterial Occlusive Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Retinal Degeneration
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Hypertension

ClinicalTrials.gov processed this record on April 16, 2014