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

NCT01717937 | Terminated

• 1 other identifier: PVOCT-12-10060
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA.

  Up to 12 months after enrollment.

Study Arms (1)

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)

Interventions

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.

PVOCT

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Any patients who are unwilling to participate or provide informed consent.
• Any patients who are pregnant at the time of enrollment.
• Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Links

• Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid.
• Noninvasive imaging of the foveal avascular zone with high-speed, phase-variance optical coherence tomography.
• In vivo volumetric imaging of human retinal circulation with phase-variance optical coherence tomography.

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Hypertensive Retinopathy; Retinal Vein Occlusion; Retinal Artery Occlusion

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Hypertension; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Arterial Occlusive Diseases

Study Officials

• Scott M McClintic, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Daniel M Schwartz, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: October 31, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

US (1)