<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/NCT02982174</url>
  </required_header>
  <id_info>
    <org_study_id>Topcon-601-2016</org_study_id>
    <nct_id>NCT02982174</nct_id>
  </id_info>
  <brief_title>Evaluation of the Signal to Noise Ratio at Various Retinal Layers</brief_title>
  <official_title>Evaluation of the Signal to Noise Ratio at Various Retinal Layers in Spectral Domain Optical Coherence Tomography (SD OCT) Compared to Swept Source Optical Coherence Tomography (SS OCT)</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>
      Compare the signal to noise ratio of each device at various retinal layers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal&#xD;
      layers from the same group of subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Signal to noise ratio between SD OCT and SS OCT</measure>
    <time_frame>5 minutes</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy Eyes</condition>
  <arm_group>
    <arm_group_label>Normal Eyes</arm_group_label>
    <description>Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D OCT-1 Maestro</intervention_name>
    <description>Image acquisition of the posterior surface of the eye</description>
    <arm_group_label>Normal Eyes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DRI OCT Triton</intervention_name>
    <description>Image acquisition of the posterior surface of the eye</description>
    <arm_group_label>Normal Eyes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        30 subjects willing to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients &gt; 18 years old who have full legal capacity to volunteer on&#xD;
             the date the informed consent is signed.&#xD;
&#xD;
          2. Subjects who can follow the instructions by the clinical staff at the clinical site,&#xD;
             and can attend examinations on the scheduled examination date.&#xD;
&#xD;
          3. Subjects who agree to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of cataract or ocular surgical procedures that render the cornea opaque or&#xD;
             otherwise impact its ability to be imaged using the investigational device.&#xD;
&#xD;
          2. Fixation problems which may prevent obtaining good quality images in either eye.&#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>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</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>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/NCT02982174
org study id: Topcon-601-2016
nct id: NCT02982174
lead sponsor: 
has dmc: Yes
Compare the signal to noise ratio of each device at various retinal layers.
Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal
      layers from the same group of subjects
observational model: Cohort
time perspective: Prospective
measure: Signal to noise ratio between SD OCT and SS OCT
time frame: 5 minutes
arm group label: Normal Eyes
description: Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton
intervention type: Device
intervention name: 3D OCT-1 Maestro
description: Image acquisition of the posterior surface of the eye
arm group label: Normal Eyes
intervention type: Device
intervention name: DRI OCT Triton
description: Image acquisition of the posterior surface of the eye
arm group label: 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: No