<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/NCT02198560</url>
  </required_header>
  <id_info>
    <org_study_id>NRL-1</org_study_id>
    <nct_id>NCT02198560</nct_id>
  </id_info>
  <brief_title>RS-3000 Lite Agreement Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nidek Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nidek Co. LTD.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the study are to assess the agreement between the two different&#xD;
      scan mode of the RS-3000 Lite.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Actual">August 2014</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>Retinal thickness and Optic Disc Analysis</measure>
    <time_frame>3 hours</time_frame>
    <description>Time frame is the maximum duration of hospital stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>1day</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Normal (Eyes without pathology)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RS-3000 Lite</intervention_name>
    <arm_group_label>Normal (Eyes without pathology)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Normal (Eyes without pathology)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not have pathology in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who have any of the following conditions:&#xD;
&#xD;
          -  Diabetes mellitus (DM) and/or diabetic retinopathy&#xD;
&#xD;
          -  Uncontrolled Hypertension (HT)&#xD;
&#xD;
          -  Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central&#xD;
             nervous system diseases affecting vision&#xD;
&#xD;
          -  Cardiac, hepatic, renal and hematologic diseases&#xD;
&#xD;
          -  A current condition requiring systemic administration of steroid&#xD;
&#xD;
          -  A history of, or currently receiving, anticancer therapy&#xD;
&#xD;
          -  Epileptic seizures which are optically induced&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
        Note: Additional criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nabeta Ganaka Iin</name>
      <address>
        <city>Okazaki</city>
        <state>Aichi</state>
        <zip>4440226</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Normal (Eyes without pathologies)</keyword>
  <!-- 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/NCT02198560
org study id: NRL-1
nct id: NCT02198560
lead sponsor: 
has dmc: No
The primary objectives of the study are to assess the agreement between the two different
      scan mode of the RS-3000 Lite.
observational model: Cohort
time perspective: Prospective
measure: Retinal thickness and Optic Disc Analysis
time frame: 3 hours
description: Time frame is the maximum duration of hospital stay.
measure: Number of participants with adverse events
time frame: 1day
arm group label: Normal (Eyes without pathology)
intervention type: Device
intervention name: RS-3000 Lite
arm group label: Normal (Eyes without pathology)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor