<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/NCT02966678</url>
  </required_header>
  <id_info>
    <org_study_id>Dyschromatopsia</org_study_id>
    <nct_id>NCT02966678</nct_id>
  </id_info>
  <brief_title>Incidence of Dyschromatopsia in Glaucoma</brief_title>
  <official_title>Incidence of Dyschromatopsia in Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incidence of dyschromatopsia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control&#xD;
      population. However, the actual incidence rate is not investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2016</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</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>Incidence of dyschromatopsia</measure>
    <time_frame>first and only study visit (day 1 of the study)</time_frame>
    <description>Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma</arm_group_label>
    <description>Patients with a diagnosis of glaucoma will undergo color vision test</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Color Vision Test</intervention_name>
    <description>Farnsworth Panel D15/Hue test plus Ishihara charts</description>
    <arm_group_label>Glaucoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of glaucoma from a university outpatient department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of glaucoma&#xD;
&#xD;
          -  age between 18 and 99 years old&#xD;
&#xD;
          -  best corrected visual acuity(BCVA) &gt; 0.2 (decimal Snellen)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 yo&#xD;
&#xD;
          -  BCVA &lt; 0.2&#xD;
&#xD;
          -  known dyschromatopsia&#xD;
&#xD;
          -  known corneal disease&#xD;
&#xD;
          -  St.p. corneal surgeries&#xD;
&#xD;
          -  macula disease&#xD;
&#xD;
          -  history of medication use that can influence color vision (e.g. hydroxychloroquine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Funk, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UniversityHospital Zurich, Dept. of Ophthalmology</affiliation>
  </overall_official>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma, Dychromatopsia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT02966678
org study id: Dyschromatopsia
nct id: NCT02966678
lead sponsor: 
has dmc: No
Incidence of dyschromatopsia
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control
      population. However, the actual incidence rate is not investigated.
observational model: Cohort
time perspective: Prospective
measure: Incidence of dyschromatopsia
time frame: first and only study visit (day 1 of the study)
description: Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.
arm group label: Glaucoma
description: Patients with a diagnosis of glaucoma will undergo color vision test
intervention type: Procedure
intervention name: Color Vision Test
description: Farnsworth Panel D15/Hue test plus Ishihara charts
arm group label: Glaucoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jens Funk, MD, PhD
role: Principal Investigator
affiliation: UniversityHospital Zurich, Dept. of Ophthalmology
responsible party type: Sponsor
mesh term: Glaucoma
sharing ipd: No