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

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Hypertensive Retinopathy; Retinal Artery Occlusion; Retinal Vein Occlusion; Age-related Macular Degeneration; Diabetic Retinopathy

Treatments: Procedure: Phase variance optical coherence tomography (PV-OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT01717937

PVOCT-12-10060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

PVOCT

Description:

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.

Treatment:

Procedure: Phase variance optical coherence tomography (PV-OCT)