<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/NCT03753893</url>
  </required_header>
  <id_info>
    <org_study_id>MTJP001</org_study_id>
    <nct_id>NCT03753893</nct_id>
  </id_info>
  <brief_title>Ocular Manifestations in Rheumatic Diseases</brief_title>
  <official_title>Prevalence of Ocular Manifestations in Inflammatory Rheumatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      This is a search strategy for determining the prevalence of ocular complications in&#xD;
      inflammatory rheumatic diseases for the purposes of a meta analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the purposes of determining the prevalence of ocular complications in inflammatory&#xD;
      rheumatic diseases, the following search terms were used: conjunctivitis,&#xD;
      keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis,&#xD;
      papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis,&#xD;
      chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.&#xD;
&#xD;
      These terms were searched in the context of a corresponding inflammatory disease on Medline,&#xD;
      Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the&#xD;
      point of study completion.&#xD;
&#xD;
      Studies were included if they provided numerical data of the prevalence or incidence of&#xD;
      ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they&#xD;
      were review articles, case reports where all patients experienced the same ocular&#xD;
      comorbidity, if different comorbidities were not grouped independently, and if the study&#xD;
      reported on fewer than 20 patients. When the same study cohort was used in more than one&#xD;
      analysis, the most recent or largest sample-size study was included. The Strengthening the&#xD;
      Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the&#xD;
      quality of cohort, case-control, and cross-sectional studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2013</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of ocular manifestations of inflammatory rheumatic diseases</measure>
    <time_frame>data is collected once per year up to 2020</time_frame>
    <description>Prevalence of ocular manifestations of inflammatory rheumatic diseases</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Uveitis</condition>
  <condition>Conjunctivitis</condition>
  <condition>Keratoconjunctivitis Sicca</condition>
  <condition>Xerophthalmia</condition>
  <condition>Eye Hemorrhage</condition>
  <condition>Optic Neuritis</condition>
  <condition>Papilledema</condition>
  <condition>Orbital Diseases</condition>
  <condition>Retinal Vein Occlusion</condition>
  <condition>Retinal Artery Occlusion</condition>
  <condition>Macular Edema</condition>
  <condition>Retinitis</condition>
  <condition>Chorioretinitis</condition>
  <condition>Iridocyclitis</condition>
  <condition>Scleritis</condition>
  <condition>Choroid Hemorrhage</condition>
  <condition>Blindness</condition>
  <condition>Amaurosis Fugax</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention used</intervention_name>
    <description>no intervention used</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ocular involvement in inflammatory rheumatic disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Studies were included if they provided numerical data of the prevalence or incidence&#xD;
             of ocular manifestations in inflammatory rheumatic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  review articles,&#xD;
&#xD;
          -  case reports where all patients experienced the same ocular comorbidity&#xD;
&#xD;
          -  if different comorbidities were not grouped independently&#xD;
&#xD;
          -  if the study reported on fewer than 20 patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet Pope, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Janet Pope</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Neuritis</mesh_term>
    <mesh_term>Optic Neuritis</mesh_term>
    <mesh_term>Blindness</mesh_term>
    <mesh_term>Papilledema</mesh_term>
    <mesh_term>Amaurosis Fugax</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Uveitis</mesh_term>
    <mesh_term>Retinitis</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Keratoconjunctivitis</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Retinal Artery Occlusion</mesh_term>
    <mesh_term>Scleritis</mesh_term>
    <mesh_term>Chorioretinitis</mesh_term>
    <mesh_term>Xerophthalmia</mesh_term>
    <mesh_term>Orbital Diseases</mesh_term>
    <mesh_term>Iridocyclitis</mesh_term>
    <mesh_term>Choroid Hemorrhage</mesh_term>
    <mesh_term>Eye Hemorrhage</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03753893
org study id: MTJP001
nct id: NCT03753893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a search strategy for determining the prevalence of ocular complications in
      inflammatory rheumatic diseases for the purposes of a meta analysis.
For the purposes of determining the prevalence of ocular complications in inflammatory
      rheumatic diseases, the following search terms were used: conjunctivitis,
      keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis,
      papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis,
      chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.

      These terms were searched in the context of a corresponding inflammatory disease on Medline,
      Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the
      point of study completion.

      Studies were included if they provided numerical data of the prevalence or incidence of
      ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they
      were review articles, case reports where all patients experienced the same ocular
      comorbidity, if different comorbidities were not grouped independently, and if the study
      reported on fewer than 20 patients. When the same study cohort was used in more than one
      analysis, the most recent or largest sample-size study was included. The Strengthening the
      Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the
      quality of cohort, case-control, and cross-sectional studies.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Prevalence of ocular manifestations of inflammatory rheumatic diseases
time frame: data is collected once per year up to 2020
description: Prevalence of ocular manifestations of inflammatory rheumatic diseases
intervention type: Other
intervention name: No intervention used
description: no intervention used
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janet Pope, MD
role: Principal Investigator
affiliation: Lawson Health Research Institute
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Janet Pope
investigator title: Professor of Medicine
mesh term: Rheumatic Diseases
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Blindness
mesh term: Papilledema
mesh term: Amaurosis Fugax
mesh term: Macular Edema
mesh term: Uveitis
mesh term: Retinitis
mesh term: Conjunctivitis
mesh term: Retinal Vein Occlusion
mesh term: Keratoconjunctivitis
mesh term: Keratoconjunctivitis Sicca
mesh term: Dry Eye Syndromes
mesh term: Retinal Artery Occlusion
mesh term: Scleritis
mesh term: Chorioretinitis
mesh term: Xerophthalmia
mesh term: Orbital Diseases
mesh term: Iridocyclitis
mesh term: Choroid Hemorrhage
mesh term: Eye Hemorrhage
mesh term: Collagen Diseases
mesh term: Hemorrhage
sharing ipd: No