<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/NCT01692938</url>
  </required_header>
  <id_info>
    <org_study_id>OPT1001</org_study_id>
    <nct_id>NCT01692938</nct_id>
  </id_info>
  <brief_title>Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO</brief_title>
  <official_title>Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optos, PLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Optos, PLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.&#xD;
      The study will assess variability across measurements taken by three different&#xD;
      operator-device configuration across clinical sites, variability between subjects within a&#xD;
      given operator-device configuration, and variability within a subject for a single&#xD;
      operator-device configuration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations</measure>
    <time_frame>1 Month</time_frame>
    <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.</measure>
    <time_frame>1 Month</time_frame>
    <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <condition>Geographic Atrophy</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Macular Edema</condition>
  <condition>Retinal Vein Occlusion</condition>
  <condition>Central Serous Retinopathy</condition>
  <condition>Pattern Dystrophy of Macula</condition>
  <condition>Epiretinal Membrane</condition>
  <condition>Macular Hole</condition>
  <arm_group>
    <arm_group_label>No Retinal Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Retinal Disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty-four subjects, 12 without retinal disease (Cohort 1) and 12 with retinal disease&#xD;
        (Cohort 2) will be recruited. Any subjects that do not comply with or complete the study&#xD;
        protocol will be replaced to ensure that a total of 24 subjects complete the protocol.&#xD;
        Subjects will be screened and recruited based on the Inclusion/Exclusion criteria outlined&#xD;
        within this protocol. Subjects fulfilling the stated criteria and who are willing to comply&#xD;
        must sign an informed consent prior form to study participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be 21 years of age or older.&#xD;
&#xD;
          -  Subjects recruited to Cohort 1 will have no known retinal disease except for&#xD;
             refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2&#xD;
             will have one or more of the following retinal pathologies: early and intermediate&#xD;
             Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild,&#xD;
             moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion,&#xD;
             Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole.&#xD;
&#xD;
          -  Subjects who have signed an informed consent form.&#xD;
&#xD;
          -  Subjects who can comply with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects younger than 21 years of age.&#xD;
&#xD;
          -  Subjects who cannot comply with the protocol.&#xD;
&#xD;
          -  Subjects who cannot complete the Simple Test procedures&#xD;
&#xD;
          -  Subjects who are not available to be testing 3 times during the day (Morning, Mid -&#xD;
             Day, and Afternoon).&#xD;
&#xD;
          -  Subjects with visual acuity worse than 20/100 (Best Corrected).&#xD;
&#xD;
          -  Subjects with dense media opacities.&#xD;
&#xD;
          -  Ocular surgery anticipated on the day of the study visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quan Nguyen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Group of Florida</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Unversity</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>July 19, 2013</results_first_submitted>
  <results_first_submitted_qc>October 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 30, 2015</results_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Retinal Perforations</mesh_term>
    <mesh_term>Geographic Atrophy</mesh_term>
    <mesh_term>Epiretinal Membrane</mesh_term>
    <mesh_term>Central Serous Chorioretinopathy</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Dates - 10/5/2012 to 11/5/2012. 3 Ophthalmic Clinics.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>No Retinal Disease</title>
        </group>
        <group group_id="P2">
          <title>Retinal Disease</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study completed prior to site completion</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Retinal Disease</title>
        </group>
        <group group_id="B2">
          <title>Retinal Disease</title>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>21-35 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36-50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65 years or great</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations</title>
        <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Retinal Disease</title>
          </group>
          <group group_id="O2">
            <title>Retinal Disease</title>
          </group>
        </group_list>
        <measure>
          <title>Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations</title>
          <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.</description>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.16" spread="1.735"/>
                    <measurement group_id="O2" value="12.23" spread="3.508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.</title>
        <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Retinal Disease</title>
          </group>
          <group group_id="O2">
            <title>Retinal Disease</title>
          </group>
        </group_list>
        <measure>
          <title>Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.</title>
          <description>A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.</description>
          <units>decibels</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Repeatability SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.16" spread="0.531"/>
                    <measurement group_id="O2" value="12.23" spread="0.682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Repeatability SD Limit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.16" spread="1.49"/>
                    <measurement group_id="O2" value="12.23" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>No Retinal Disease</title>
        </group>
        <group group_id="E2">
          <title>Retinal Disease</title>
        </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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Quan Nguyen, MD Director of the Stanley M. Truhlsen Eye Institute</name_or_title>
      <organization>Stanley M. Truhlsen Eye Institute</organization>
      <phone>402-559-4276</phone>
      <email>quan.nguyen@unmc.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/NCT01692938
org study id: OPT1001
nct id: NCT01692938
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.
      The study will assess variability across measurements taken by three different
      operator-device configuration across clinical sites, variability between subjects within a
      given operator-device configuration, and variability within a subject for a single
      operator-device configuration.
observational model: Case-Only
time perspective: Prospective
measure: Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations
time frame: 1 Month
description: A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.
measure: Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.
time frame: 1 Month
description: A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.
arm group label: No Retinal Disease
arm group label: Retinal Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Quan Nguyen
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Macular Edema
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Retinal Vein Occlusion
mesh term: Retinal Perforations
mesh term: Geographic Atrophy
mesh term: Epiretinal Membrane
mesh term: Central Serous Chorioretinopathy
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 