<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/NCT04417244</url>
  </required_header>
  <id_info>
    <org_study_id>2020 ADV-OPH</org_study_id>
    <nct_id>NCT04417244</nct_id>
  </id_info>
  <brief_title>Adenovirus Keratoconjunctivitis and Ophtalmology</brief_title>
  <acronym>ADV-OPH</acronym>
  <official_title>Complications of Adenovirus Keratoconjunctivitis in Ophthalmologists and Orthoptists: Epidemiology and Risk Factor, a Retrospective Questionnaire Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease&#xD;
      for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after&#xD;
      infection.&#xD;
&#xD;
      The primary aim of the study is to investigate the prevalence of these sequelae in the&#xD;
      at-risk population of ophthalmologists and orthoptist.&#xD;
&#xD;
      Secondary aim are to describe administrative procedures (occupational disease declaration and&#xD;
      sick leave),infections characteristics; and risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease&#xD;
      for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after&#xD;
      infection.&#xD;
&#xD;
      The investigation tream create a nationwide anonymous retrospective questionnaire using the&#xD;
      secure internet application REDCap® to build and manage the questionnaire addressed to&#xD;
      ophtalmologists (interns, graduates and retirees) and orthoptists.&#xD;
&#xD;
      Investigator collect several characteristics such as general characteristics (sex, age range,&#xD;
      profession), administrative procedure declaration (occupational disease declaration, sick&#xD;
      leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority,&#xD;
      sequels, current therapy, professional discomfort), risk factor (refractive surgery history,&#xD;
      wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy).&#xD;
&#xD;
      The primary aim of the study is to investigate the prevalence of these sequelae in the&#xD;
      at-risk population of ophthalmologists and orthoptist. Secondary aim are to describe&#xD;
      administrative procedures (occupational disease declaration and sick leave), infections&#xD;
      characteristics; and risk factors such as a refractive surgery history, the wearing of&#xD;
      eyeglasses or contact lenses, smoking, or corticosteroid therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 21, 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>epidemiology characteristics</measure>
    <time_frame>Day 1</time_frame>
    <description>history of adenovirus keratoconjunctivitis; history of sequels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general characteristics - Sex</measure>
    <time_frame>Day 1</time_frame>
    <description>general characteristics - Sex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general characteristics - Age range</measure>
    <time_frame>Day 1</time_frame>
    <description>general characteristics - Age range</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general characteristics - Profession</measure>
    <time_frame>Day 1</time_frame>
    <description>general characteristics - Profession</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>administrative procedure declaration</measure>
    <time_frame>Day 1</time_frame>
    <description>occupational disease declaration, sick leave, cessation of surgery and duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>infection characteristics</measure>
    <time_frame>Day 1</time_frame>
    <description>bilaterality, season, anteriority, sequels, current therapy, professional discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>risk factor</measure>
    <time_frame>Day 1</time_frame>
    <description>refractive surgery history, wearing of eyeglasses or contact lenses, smoking, corticosteroid therapy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Adenoviral Keratoconjunctivitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        French Ophtalmologist or orthoptist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ophtalmologist or orthoptist (interns, graduates and retirees)&#xD;
&#xD;
          -  French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Foreign practitionner&#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_contact>
    <last_name>Lise Laclautre</last_name>
    <phone>0473754963</phone>
    <email>pormo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University hospital, Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>0473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Frédéric Dutheil, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Margaux Metzger, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenovirus</keyword>
  <keyword>Epidemic Keratoconjunctivitis</keyword>
  <keyword>Subepithelial infiltrates</keyword>
  <keyword>Occupational diseases</keyword>
  <keyword>Ophtalmologists</keyword>
  <keyword>Orthoptists</keyword>
  <keyword>Epidemiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoviridae Infections</mesh_term>
    <mesh_term>Keratoconjunctivitis</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/NCT04417244
org study id: 2020 ADV-OPH
nct id: NCT04417244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease
      for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after
      infection.

      The primary aim of the study is to investigate the prevalence of these sequelae in the
      at-risk population of ophthalmologists and orthoptist.

      Secondary aim are to describe administrative procedures (occupational disease declaration and
      sick leave),infections characteristics; and risk factors.
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease
      for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after
      infection.

      The investigation tream create a nationwide anonymous retrospective questionnaire using the
      secure internet application REDCap® to build and manage the questionnaire addressed to
      ophtalmologists (interns, graduates and retirees) and orthoptists.

      Investigator collect several characteristics such as general characteristics (sex, age range,
      profession), administrative procedure declaration (occupational disease declaration, sick
      leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority,
      sequels, current therapy, professional discomfort), risk factor (refractive surgery history,
      wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy).

      The primary aim of the study is to investigate the prevalence of these sequelae in the
      at-risk population of ophthalmologists and orthoptist. Secondary aim are to describe
      administrative procedures (occupational disease declaration and sick leave), infections
      characteristics; and risk factors such as a refractive surgery history, the wearing of
      eyeglasses or contact lenses, smoking, or corticosteroid therapy.
observational model: Case-Control
time perspective: Retrospective
measure: epidemiology characteristics
time frame: Day 1
description: history of adenovirus keratoconjunctivitis; history of sequels
measure: general characteristics - Sex
time frame: Day 1
description: general characteristics - Sex
measure: general characteristics - Age range
time frame: Day 1
description: general characteristics - Age range
measure: general characteristics - Profession
time frame: Day 1
description: general characteristics - Profession
measure: administrative procedure declaration
time frame: Day 1
description: occupational disease declaration, sick leave, cessation of surgery and duration
measure: infection characteristics
time frame: Day 1
description: bilaterality, season, anteriority, sequels, current therapy, professional discomfort
measure: risk factor
time frame: Day 1
description: refractive surgery history, wearing of eyeglasses or contact lenses, smoking, corticosteroid therapy
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: Lise Laclautre
phone: 0473754963
email: pormo_interne_drci@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Adenoviridae Infections
mesh term: Keratoconjunctivitis