<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717937</url>
  </required_header>
  <id_info>
    <org_study_id>PVOCT-12-10060</org_study_id>
    <nct_id>NCT01717937</nct_id>
  </id_info>
  <brief_title>Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging</brief_title>
  <acronym>PVOCT</acronym>
  <official_title>Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether phase variance optical coherence tomography&#xD;
      (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can&#xD;
      be used to generate angiographic images of the retinochoroidal vasculature that are&#xD;
      comparable to those produced by fluorescein angiography (FA), the current gold standard&#xD;
      diagnostic test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fluorescein angiography (FA) has long been the gold standard for vascular imaging of the&#xD;
      retina and choroid. It is a test that involves the intravenous injection of fluorescein dye,&#xD;
      followed by imaging of the dye's passage through the blood vessels inside the eye. It is&#xD;
      commonly used to diagnose many forms of retinovascular disease, as well as to assess the&#xD;
      retina's response to various therapeutic interventions. While FA is a relatively safe&#xD;
      diagnostic test, it carries the risk of both minor and major side effects. These include&#xD;
      nausea and vomiting, yellowing of the skin and urine, vascular extravasation with skin&#xD;
      eruption and necrosis, vasovagal reactions, myocardial infarction, respiratory failure,&#xD;
      anaphylaxis, cardiopulmonary arrest, and death. Additionally, the test is time-consuming,&#xD;
      technically difficult to perform, and requires patients to undergo the discomfort associated&#xD;
      with intravenous access. Despite these drawbacks, FA is still commonly used in clinical&#xD;
      practice, as there are no existing alternative tests with the ability to provide comparable&#xD;
      detail of the retinal and choroidal vasculature.&#xD;
&#xD;
      Phase-variance optical coherence tomography is a novel, noninvasive, software-based&#xD;
      technology capable of generating angiographic images from the data gathered by standard OCT&#xD;
      scans. Preliminary research suggests it can produce high-definition representations of the&#xD;
      retinal and choroidal vasculature which may be more detailed than the images produced by FA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient enrollment&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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).</measure>
    <time_frame>On the day in which a patient receives PV-OCT and FA imaging, estimated to take 2 hours.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA.</measure>
    <time_frame>Up to 12 months after enrollment.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Hypertensive Retinopathy</condition>
  <condition>Retinal Vein Occlusion</condition>
  <condition>Retinal Artery Occlusion</condition>
  <arm_group>
    <arm_group_label>PVOCT</arm_group_label>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phase variance optical coherence tomography (PV-OCT)</intervention_name>
    <description>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.</description>
    <arm_group_label>PVOCT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients seen in the University of California, San Francisco Retina Clinic with&#xD;
        suspected or established retinovascular disease and who are scheduled to undergo&#xD;
        fluorescein angiography as part of their normal clinical evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with suspected or established retinovascular disease who are going to undergo&#xD;
             FA as part of their usual clinical evaluation.&#xD;
&#xD;
          2. Patients must be age 13 or above.&#xD;
&#xD;
          3. Patients must be able to speak and understand the English language in order to provide&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any patients who are unwilling to participate or provide informed consent.&#xD;
&#xD;
          2. Any patients who are pregnant at the time of enrollment.&#xD;
&#xD;
          3. Any patients with ocular media opacities which prevent clear evaluation of the fundus&#xD;
             by either FA or OCT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott M McClintic, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel M Schwartz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/18566457</url>
    <description>Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22125275</url>
    <description>Noninvasive imaging of the foveal avascular zone with high-speed, phase-variance optical coherence tomography.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/21698014</url>
    <description>In vivo volumetric imaging of human retinal circulation with phase-variance optical coherence tomography.</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>retinovascular disease</keyword>
  <keyword>imaging</keyword>
  <keyword>fluorescein angiography</keyword>
  <keyword>FA</keyword>
  <keyword>angiography</keyword>
  <keyword>optical coherence tomography</keyword>
  <keyword>OCT</keyword>
  <keyword>phase variance</keyword>
  <keyword>comparison</keyword>
  <keyword>age-related macular degeneration</keyword>
  <keyword>diabetic retinopathy</keyword>
  <keyword>hypertensive retinopathy</keyword>
  <keyword>retinal vein occlusion</keyword>
  <keyword>retinal artery occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Retinal Artery Occlusion</mesh_term>
    <mesh_term>Hypertensive Retinopathy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717937
org study id: PVOCT-12-10060
nct id: NCT01717937
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
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.
description: 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.
measure: 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.
description: 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.
arm group label: 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.
intervention type: Procedure
intervention name: Phase variance optical coherence tomography (PV-OCT)
description: 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.
arm group label: PVOCT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Scott M McClintic, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Daniel M Schwartz, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
url: http://www.ncbi.nlm.nih.gov/pubmed/18566457
description: Phase-contrast OCT imaging of transverse flows in the mouse retina and choroid.
url: http://www.ncbi.nlm.nih.gov/pubmed/22125275
description: Noninvasive imaging of the foveal avascular zone with high-speed, phase-variance optical coherence tomography.
url: http://www.ncbi.nlm.nih.gov/pubmed/21698014
description: In vivo volumetric imaging of human retinal circulation with phase-variance optical coherence tomography.
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Retinal Vein Occlusion
mesh term: Retinal Artery Occlusion
mesh term: Hypertensive Retinopathy