Clinical trial NCT01717937: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging
Official title: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age-related Macular Degeneration
Diabetic Retinopathy
Hypertensive Retinopathy
Retinal Vein Occlusion
Retinal Artery Occlusion
Keywords: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Measurement of to be determined physical characteristics of retinovascular structures seen on phase variance optical coherence tomography (PV-OCT) and fluorescein angiography(FA).
timeFrame: On the day in which a patient receives PV-OCT and FA imaging, estimated to take 2 hours.
Secondary outcomes:
measure: Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA.
timeFrame: Up to 12 months after enrollment.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Scott M McClintic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Daniel M Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: