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insufficient enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase variance optical coherence tomography (PV-OCT) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of to be determined physical characteristics of retinovascular structures seen on phase variance optical coherence tomography (PV-OCT) and fluorescein angiography(FA). | 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. | On the day in which a patient receives PV-OCT and FA imaging, estimated to take 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Scott M McClintic, M.D. | University of California, San Francisco | Principal Investigator |
| Daniel M Schwartz, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94118 | United States |
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| Label | URL |
|---|---|
| Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid. | View source |
| Noninvasive imaging of the foveal avascular zone with high-speed, phase-variance optical coherence tomography. | View source |
| In vivo volumetric imaging of human retinal circulation with phase-variance optical coherence tomography. |
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| Up to 12 months after enrollment. |
| View source |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D058437 | Hypertensive Retinopathy |
| D012170 | Retinal Vein Occlusion |
| D015356 | Retinal Artery Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D001157 | Arterial Occlusive Diseases |
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