<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/NCT04458012</url>
  </required_header>
  <id_info>
    <org_study_id>EPISTA1</org_study_id>
    <nct_id>NCT04458012</nct_id>
  </id_info>
  <brief_title>Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections</brief_title>
  <acronym>EPISTA1</acronym>
  <official_title>Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients With Age-related Macular Degeneration Treated With Intravitreal Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tor Paaske Utheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vegard Asgeir Forsaa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vilde Marie Thomseth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate prevalence of dry eye disease in Norwegian patients with age-related macular&#xD;
      degeneration receiving intravitreal injections, as well as to reveal possible risk factors of&#xD;
      DED in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for&#xD;
      objective ocular surface evaluation. Tear fluid samples will be collected for later&#xD;
      biochemical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 25, 2023</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>Dry eye disease in patients receiving intravitreal injections</measure>
    <time_frame>2022</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Dry Eye</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Oculus Keratograph. Schirmer test. Tear fluid sample.</intervention_name>
    <description>Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tear fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with age related macular degeneration receiving intravitreal injections with&#xD;
        anti-vegf.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AMD diagnosis&#xD;
&#xD;
          -  Treated with intravitreal injection agents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to cooperate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stavanger University Hospital, Department of Ophthalmology</name>
      <address>
        <city>Stavanger</city>
        <zip>4068</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helse Stavanger HF</investigator_affiliation>
    <investigator_full_name>Agni Malmin</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <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/NCT04458012
org study id: EPISTA1
nct id: NCT04458012
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate prevalence of dry eye disease in Norwegian patients with age-related macular
      degeneration receiving intravitreal injections, as well as to reveal possible risk factors of
      DED in this population.
Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for
      objective ocular surface evaluation. Tear fluid samples will be collected for later
      biochemical analysis.
observational model: Cohort
time perspective: Prospective
measure: Dry eye disease in patients receiving intravitreal injections
time frame: 2022
intervention type: Diagnostic Test
intervention name: Oculus Keratograph. Schirmer test. Tear fluid sample.
description: Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips.
Tear fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Helse Stavanger HF
investigator full name: Agni Malmin
investigator title: MD
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
sharing ipd: No