Age-related Macular DegenerationPVOCTNCT01717937
Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging
An observational study of Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Diabetic Retinopathy, Hypertensive Retinopathy
- What is being tested?
- Phase variance optical coherence tomography (PV-OCT)
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease
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.
Read the 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.
- Conditions
- Age-related Macular Degeneration, Diabetic Retinopathy, Hypertensive Retinopathy, Retinal Vein Occlusion, Retinal Artery Occlusion
- Being tested
- Phase variance optical coherence tomography (PV-OCT)
- 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
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Hypertensive Retinopathy, Retinal Vein Occlusion, Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase variance optical coherence tomography (PV-OCT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Phase variance optical coherence tomography (PV-OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Up to 12 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott M McClintic, M.D., Principal investigator, University of California, San FranciscoDaniel M Schwartz, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717937
- Sponsor's protocol ID
- PVOCT-12-10060
- Acronym
- PVOCT
- Status last verified
- Sep 2014
- First submitted
- 28 Oct 2012
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease
- ClinicalTrials.gov ID
- NCT01717937
- Acronym / sponsor ID
- PVOCT / PVOCT-12-10060
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVOCT | – | Procedure: Phase variance optical coherence tomography (PV-OCT)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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | PVOCT |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid.Link provided by the sponsor.
- Noninvasive imaging of the foveal avascular zone with high-speed, phase-variance optical coherence tomography.Link provided by the sponsor.
- In vivo volumetric imaging of human retinal circulation with phase-variance optical coherence tomography.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M McClintic, M.D. principal investigator
University of California, San Francisco
Daniel M Schwartz, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.