<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/NCT03030729</url>
  </required_header>
  <id_info>
    <org_study_id>TLV-0025-16</org_study_id>
    <nct_id>NCT03030729</nct_id>
  </id_info>
  <brief_title>Macular Thickness Measurements Using Retinal-thickness OCT</brief_title>
  <official_title>Macular Thickness Measurements Using RTOCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Notal Vision Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Notal Vision Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a&#xD;
      commercial OCT (Optical Coherence Tomography)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">January 14, 2018</completion_date>
  <primary_completion_date type="Actual">January 14, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between retinal measurements, done by the RTOCT device and a commercial OCT</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Intermediate AMD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Advanced AMD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>DR without macular edema</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>DR with macular edema</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. AMD population - intermediate and advanced AMD (with active and non-active CNV)&#xD;
&#xD;
          2. DR population. Patient with and without DME&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability and agreement to give informed consent (IC)&#xD;
&#xD;
          2. Diagnosis of AMD or DR in SE by OCT&#xD;
&#xD;
          3. Ability to undergo OCT scans&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. AMD and DR in the same SE&#xD;
&#xD;
          2. Evidence of macular disease other than AMD or DME in SE&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sorasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT03030729
org study id: TLV-0025-16
nct id: NCT03030729
lead sponsor: 
has dmc: No
Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a
      commercial OCT (Optical Coherence Tomography)
observational model: Other
time perspective: Prospective
measure: Comparison between retinal measurements, done by the RTOCT device and a commercial OCT
time frame: 1 year
arm group label: Intermediate AMD
arm group label: Advanced AMD
arm group label: DR without macular edema
arm group label: DR with macular edema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Diabetic Retinopathy