<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/NCT03783858</url>
  </required_header>
  <id_info>
    <org_study_id>OPT1030</org_study_id>
    <nct_id>NCT03783858</nct_id>
  </id_info>
  <brief_title>Image Collection of Normal Eyes for Development of an EU RDB</brief_title>
  <official_title>Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optos, PLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Optos, PLC</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy&#xD;
      eyes to develop a EU reference database&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal thickness</measure>
    <time_frame>1 day</time_frame>
    <description>In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters.&#xD;
The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">356</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Single</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>P200TE</intervention_name>
    <description>OCT images</description>
    <arm_group_label>Single</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject 22 years of age or older on the date of informed consent&#xD;
&#xD;
          2. Subject able to understand the written informed consent and willing to participate as&#xD;
             evidenced by signing the informed consent&#xD;
&#xD;
          3. Subject presenting at the site with normal eyes* (Cataracts and LASIK and PRK are&#xD;
             allowed)&#xD;
&#xD;
          4. BCVA 20/40 or better (each eye)&#xD;
&#xD;
          5. Subject is able to comply with the study procedures in the view of the investigator&#xD;
             *Normal eyes are defined as eyes judged normal for the subjects age as determined by&#xD;
             the PI or sub-investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not&#xD;
        sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or&#xD;
        multiple sclerosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tunde Peto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queens University Belfast</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simon Browning Optometrist</name>
      <address>
        <city>Bedford</city>
        <state>England</state>
        <zip>MK40 2SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnard Levit Optometrists</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>NW11 7EL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Vision Clinic</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>W1G 7LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens University</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <zip>BT7 1NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cameron Optometry</name>
      <address>
        <city>Edinburgh</city>
        <state>Scotland</state>
        <zip>EH3 6SW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03783858
org study id: OPT1030
nct id: NCT03783858
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy
      eyes to develop a EU reference database
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Retinal thickness
time frame: 1 day
description: In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters.
The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.
arm group label: Single
arm group type: Other
intervention type: Device
intervention name: P200TE
description: OCT images
arm group label: Single
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tunde Peto, PhD
role: Principal Investigator
affiliation: Queens University Belfast
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No