<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/NCT01667861</url>
  </required_header>
  <id_info>
    <org_study_id>NL25853.068.09/MEC09-2-112</org_study_id>
    <nct_id>NCT01667861</nct_id>
  </id_info>
  <brief_title>Risk Factors for Glaucoma in Musicians</brief_title>
  <official_title>Risk Factors for Glaucoma in Musicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henny Beckers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stichting Glaucoomfonds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the impact of playing wind instruments for the&#xD;
      development of ocular hypertension and glaucoma, together with investigating the prevalence&#xD;
      of visual problems and eye diseases in (professional) musicians.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.</measure>
    <time_frame>One hour.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP peaks and variations during continuous IOP monitoring</measure>
    <time_frame>24 hours</time_frame>
    <description>Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians</measure>
    <time_frame>2 years</time_frame>
    <description>Participants of orchestras will be asked to fill in a questionnaire to collect demographic data together with data on musical history,ophthalmologic history and family history on glaucoma and ocular hypertension. From these participants, a selection will be invited for further screening.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>(Wind) musicians</arm_group_label>
    <description>Members of (professional) orchestras, especially wind instrument players.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        (Professional) musicians, who play in symphony or wind orchestras.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All full time or part time professional players of participating symphony or wind&#xD;
             orchestras, including guest players.&#xD;
&#xD;
          -  Retired players, if possible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficulty in reading or speaking Dutch.&#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>Henny JM Beckers, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center, NL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Eye Clinic, Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>May 22, 2015</last_update_submitted>
  <last_update_submitted_qc>May 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University Medical Center</investigator_affiliation>
    <investigator_full_name>Henny Beckers</investigator_full_name>
    <investigator_title>MD, PhD, FEBophth</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Wind instruments</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT01667861
org study id: NL25853.068.09/MEC09-2-112
nct id: NCT01667861
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the impact of playing wind instruments for the
      development of ocular hypertension and glaucoma, together with investigating the prevalence
      of visual problems and eye diseases in (professional) musicians.
time perspective: Cross-Sectional
measure: IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.
time frame: One hour.
measure: IOP peaks and variations during continuous IOP monitoring
time frame: 24 hours
description: Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.
measure: Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians
time frame: 2 years
description: Participants of orchestras will be asked to fill in a questionnaire to collect demographic data together with data on musical history,ophthalmologic history and family history on glaucoma and ocular hypertension. From these participants, a selection will be invited for further screening.
arm group label: (Wind) musicians
description: Members of (professional) orchestras, especially wind instrument players.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Henny JM Beckers, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center, NL
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Maastricht University Medical Center
investigator full name: Henny Beckers
investigator title: MD, PhD, FEBophth
mesh term: Glaucoma