<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/NCT02235454</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00056471</org_study_id>
    <nct_id>NCT02235454</nct_id>
  </id_info>
  <brief_title>SDOCT-GMPE Software</brief_title>
  <official_title>A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for&#xD;
      spectral domain optical coherence tomography (SDOCT) and if this software is superior to the&#xD;
      conventional one that is currently used for SDOCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The new GMPE software can now identify the ocular structures without input from the operator&#xD;
      thus reducing operator induced errors. It also measures the thickness of the entire optic&#xD;
      nerve head so as to allow for another anatomic area of the eye to be measured for assessment&#xD;
      of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data&#xD;
      in three concentric circles instead of just one in order to account for different sizes of&#xD;
      optic nerves.&#xD;
&#xD;
      Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye&#xD;
      Center and its associated satellite clinics. Following informed consent, subjects undergo&#xD;
      additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated&#xD;
      satellite clinics. The imaging results may be used in clinical care for the subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">August 1, 2016</completion_date>
  <primary_completion_date type="Actual">August 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)</measure>
    <time_frame>imaging approximately 10 minutes</time_frame>
    <description>Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Consecutive patients with glaucoma will undergo non-invasive OCT imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SDOCT-GMPE software</intervention_name>
    <description>Noninvasive imaging of the optic nerve in patients with existing glaucoma</description>
    <arm_group_label>Glaucoma arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  capable and willing to provide consent&#xD;
&#xD;
          -  history of clinically-diagnosed glaucoma&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable or unwilling to give consent&#xD;
&#xD;
          -  under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanjay Asrani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>June 26, 2017</results_first_submitted>
  <results_first_submitted_qc>June 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2017</results_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>OCT</keyword>
  <keyword>spectral domain optical coherence tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Glaucoma Arm</title>
          <description>Consecutive patients with glaucoma will undergo non-invasive OCT imaging&#xD;
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Glaucoma Arm</title>
          <description>Consecutive patients with glaucoma will undergo non-invasive OCT imaging&#xD;
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.5" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)</title>
        <description>Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).</description>
        <time_frame>imaging approximately 10 minutes</time_frame>
        <population>All usable images of one eye of each participant</population>
        <group_list>
          <group group_id="O1">
            <title>Glaucoma Arm</title>
            <description>Consecutive patients with glaucoma will undergo non-invasive OCT imaging&#xD;
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma</description>
          </group>
        </group_list>
        <measure>
          <title>Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)</title>
          <description>Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).</description>
          <population>All usable images of one eye of each participant</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During measurement time (approximately ten minutes)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Glaucoma Arm</title>
          <description>Consecutive willing patients with glaucoma will undergo non-invasive OCT imaging&#xD;
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sanjay Asrani</name_or_title>
      <organization>Duke University</organization>
      <phone>919-684-8656</phone>
      <email>sanjay.asrani@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02235454
org study id: Pro00056471
nct id: NCT02235454
lead sponsor: 
has dmc: Yes
The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for
      spectral domain optical coherence tomography (SDOCT) and if this software is superior to the
      conventional one that is currently used for SDOCT.
The new GMPE software can now identify the ocular structures without input from the operator
      thus reducing operator induced errors. It also measures the thickness of the entire optic
      nerve head so as to allow for another anatomic area of the eye to be measured for assessment
      of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data
      in three concentric circles instead of just one in order to account for different sizes of
      optic nerves.

      Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye
      Center and its associated satellite clinics. Following informed consent, subjects undergo
      additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated
      satellite clinics. The imaging results may be used in clinical care for the subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)
time frame: imaging approximately 10 minutes
description: Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).
arm group label: Glaucoma arm
arm group type: Other
description: Consecutive patients with glaucoma will undergo non-invasive OCT imaging
intervention type: Device
intervention name: SDOCT-GMPE software
description: Noninvasive imaging of the optic nerve in patients with existing glaucoma
arm group label: Glaucoma arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sanjay Asrani, MD
role: Principal Investigator
affiliation: Duke Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 