<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/NCT03022383</url>
  </required_header>
  <id_info>
    <org_study_id>Topcon Triton 1222-2016</org_study_id>
    <nct_id>NCT03022383</nct_id>
  </id_info>
  <brief_title>TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus</brief_title>
  <official_title>TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Topcon Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Topcon Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scans with a TopQ score below the optimum cut-off should be considered to be poor or&#xD;
      unacceptable quality, and scans with a TopQ score above the cut-off should be considered good&#xD;
      or acceptable quality. The study will evaluate the predetermined cut-off values by&#xD;
      investigating measurement variability of scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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 Variability of Signal to Noise Ratio</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy Eyes</condition>
  <arm_group>
    <arm_group_label>Subjects Presenting With Normal Eyes</arm_group_label>
    <description>Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DRI OCT Triton plus</intervention_name>
    <description>OCT Machine used for diagnostic purposes</description>
    <arm_group_label>Subjects Presenting With Normal Eyes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with no known eye disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Participants must be at least 18 years of age&#xD;
&#xD;
          -  Participants must be able to complete all testing (all OCT scans)&#xD;
&#xD;
          -  Participants must volunteer to be in the study and sign the consent form&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subject with history of ocular disease or ocular pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Chieh Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Topcon Medical Systems, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Topcon Medical Systems Inc.</name>
      <address>
        <city>Oakland</city>
        <state>New Jersey</state>
        <zip>07436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>June 6, 2022</last_update_submitted>
  <last_update_submitted_qc>June 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>no known ocular pathology</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03022383
org study id: Topcon Triton 1222-2016
nct id: NCT03022383
lead sponsor: 
has dmc: No
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus
Scans with a TopQ score below the optimum cut-off should be considered to be poor or
      unacceptable quality, and scans with a TopQ score above the cut-off should be considered good
      or acceptable quality. The study will evaluate the predetermined cut-off values by
      investigating measurement variability of scans.
observational model: Cohort
time perspective: Prospective
measure: Measurement Variability of Signal to Noise Ratio
time frame: 1 hour
arm group label: Subjects Presenting With Normal Eyes
description: Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device
intervention type: Device
intervention name: DRI OCT Triton plus
description: OCT Machine used for diagnostic purposes
arm group label: Subjects Presenting With Normal Eyes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wei-Chieh Huang, PhD
role: Principal Investigator
affiliation: Topcon Medical Systems, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided