<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/NCT03279939</url>
  </required_header>
  <id_info>
    <org_study_id>S-2017-1</org_study_id>
    <nct_id>NCT03279939</nct_id>
  </id_info>
  <brief_title>Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module</brief_title>
  <official_title>Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg Engineering GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg Engineering GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of image quality and clinical relevance of OCT Angiography via comparison to&#xD;
      FA/ICGA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are:&#xD;
&#xD;
        1. To compare the OCTA image quality between the SPECTRALIS and the predicate.&#xD;
&#xD;
        2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OCTA image quality</measure>
    <time_frame>day 1</time_frame>
    <description>Image quality grading results of study selected images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically relevant findings on OCTA</measure>
    <time_frame>day 1</time_frame>
    <description>Clinically relevant grading results of study selected images</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Retinal Vascular</condition>
  <condition>Normal Eyes</condition>
  <arm_group>
    <arm_group_label>Subjects with Normal Eyes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with Pathology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT Angiography</intervention_name>
    <description>OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.</description>
    <arm_group_label>Subjects with Normal Eyes</arm_group_label>
    <arm_group_label>Subjects with Pathology</arm_group_label>
    <other_name>OCTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Color Fundus Photography</intervention_name>
    <description>Non-contact white light photography.</description>
    <arm_group_label>Subjects with Normal Eyes</arm_group_label>
    <arm_group_label>Subjects with Pathology</arm_group_label>
    <other_name>CFP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluorescein Angiography</intervention_name>
    <description>An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.</description>
    <arm_group_label>Subjects with Normal Eyes</arm_group_label>
    <arm_group_label>Subjects with Pathology</arm_group_label>
    <other_name>FA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indocyaine Green Angiography</intervention_name>
    <description>An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.</description>
    <arm_group_label>Subjects with Pathology</arm_group_label>
    <other_name>ICGA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects:&#xD;
&#xD;
          -  Able and willing to undergo the test procedures, sign informed consent, and follow&#xD;
             instructions.&#xD;
&#xD;
          -  Age ≥ 22&#xD;
&#xD;
        Subjects with Normal Eyes:&#xD;
&#xD;
          -  Subjects presenting at the site without uncontrolled systemic conditions, or ocular&#xD;
             disease, as determined by the Investigator&#xD;
&#xD;
          -  Corrected visual acuity ≥ 20/40 in each eye&#xD;
&#xD;
          -  No history of ocular surgical intervention (except for refractive or cataract surgery)&#xD;
             in either eye&#xD;
&#xD;
        Subjects with Pathology:&#xD;
&#xD;
          -  Subjects with retinal conditions in at least one eye.&#xD;
&#xD;
          -  Subjects included can have a range of retinal vascular pathologies affecting different&#xD;
             anatomic depths through the retina and choroid. Retinal conditions including but not&#xD;
             limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and&#xD;
             branch or central retinal vein occlusion that give rise to features such as retinal&#xD;
             ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization&#xD;
             will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable to read or write&#xD;
&#xD;
          -  Subjects with ocular media not sufficiently clear to obtain acceptable study-related&#xD;
             imaging&#xD;
&#xD;
          -  Subjects who cannot tolerate the imaging procedures&#xD;
&#xD;
          -  Subjects with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish,&#xD;
             drugs for pupillary dilation&#xD;
&#xD;
          -  Subjects with contraindication to pupillary dilation in study eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retina Consultants Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03279939
org study id: S-2017-1
nct id: NCT03279939
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Assessment of image quality and clinical relevance of OCT Angiography via comparison to
      FA/ICGA.
The objectives of this study are:

        1. To compare the OCTA image quality between the SPECTRALIS and the predicate.

        2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: OCTA image quality
time frame: day 1
description: Image quality grading results of study selected images
measure: Clinically relevant findings on OCTA
time frame: day 1
description: Clinically relevant grading results of study selected images
arm group label: Subjects with Normal Eyes
arm group type: Experimental
description: OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology.
arm group label: Subjects with Pathology
arm group type: Experimental
description: OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology.
intervention type: Device
intervention name: OCT Angiography
description: OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
arm group label: Subjects with Normal Eyes
arm group label: Subjects with Pathology
other name: OCTA
intervention type: Device
intervention name: Color Fundus Photography
description: Non-contact white light photography.
arm group label: Subjects with Normal Eyes
arm group label: Subjects with Pathology
other name: CFP
intervention type: Device
intervention name: Fluorescein Angiography
description: An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
arm group label: Subjects with Normal Eyes
arm group label: Subjects with Pathology
other name: FA
intervention type: Device
intervention name: Indocyaine Green Angiography
description: An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.
arm group label: Subjects with Pathology
other name: ICGA
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Brown, MD
role: Principal Investigator
affiliation: Retina Consultants Houston
facility: 
country: United States
responsible party type: Sponsor