<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/NCT02991027</url>
  </required_header>
  <id_info>
    <org_study_id>Topcon Tabil-801-2016</org_study_id>
    <nct_id>NCT02991027</nct_id>
  </id_info>
  <brief_title>OCT Image Quality Performance Evaluation</brief_title>
  <official_title>OCT Image Quality Performance Evaluation</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton&#xD;
      devices using two light sources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton&#xD;
      devices using two light sources with equivalent specifications: the micro-electro-mechanical&#xD;
      short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface&#xD;
      emitting laser.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects needed for enrollment anymore&#xD;
  </why_stopped>
  <start_date type="Actual">December 14, 2016</start_date>
  <completion_date type="Actual">July 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OCT image quality</measure>
    <time_frame>5 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>OCT angiography image quality</measure>
    <time_frame>5 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Full Retinal Thickness</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Eyes</condition>
  <arm_group>
    <arm_group_label>Subjects Presenting With Normal Eyes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DRI OCT Triton</intervention_name>
    <description>DRI OCT Triton using micro-electro-mechanical short cavity tunable laser</description>
    <arm_group_label>Subjects Presenting With Normal Eyes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DRI OCT Triton</intervention_name>
    <description>DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser</description>
    <arm_group_label>Subjects Presenting With Normal Eyes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Participants must be at least 18 years of age&#xD;
&#xD;
          2. They must be able to complete all testing (all OCT scans)&#xD;
&#xD;
          3. They must volunteer to be in the study and sign the consent form&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subject with history of ocular disease or ocular pathology&#xD;
&#xD;
          2. Subjects unable to complete all OCT imaging modes&#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>Zhenguo Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Topcon Corporation</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>October 2021</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>no known ocular pathology</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02991027
org study id: Topcon Tabil-801-2016
nct id: NCT02991027
lead sponsor: 
has dmc: Yes
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton
      devices using two light sources.
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton
      devices using two light sources with equivalent specifications: the micro-electro-mechanical
      short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface
      emitting laser.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: OCT image quality
time frame: 5 minutes
measure: OCT angiography image quality
time frame: 5 minutes
measure: Full Retinal Thickness
time frame: 5 minutes
arm group label: Subjects Presenting With Normal Eyes
arm group type: Experimental
description: Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton
intervention type: Device
intervention name: DRI OCT Triton
description: DRI OCT Triton using micro-electro-mechanical short cavity tunable laser
arm group label: Subjects Presenting With Normal Eyes
intervention type: Device
intervention name: DRI OCT Triton
description: DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser
arm group label: Subjects Presenting With Normal Eyes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zhenguo Wang, PhD
role: Principal Investigator
affiliation: Topcon Corporation
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No