<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/NCT01695161</url>
  </required_header>
  <id_info>
    <org_study_id>MZ-MPS-2012-01</org_study_id>
    <nct_id>NCT01695161</nct_id>
  </id_info>
  <brief_title>Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.</brief_title>
  <acronym>MPSORA</acronym>
  <official_title>Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to compare intraocular pressure (IOP) values assessed with&#xD;
      Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann&#xD;
      applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want&#xD;
      to investigate biomechanical characteristics of the cornea and their influence on the&#xD;
      IOP-measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>agreement between ccIOP and GAT in MPS, Fabry and healthy controls</measure>
    <time_frame>Sep 2013 (anticipated)</time_frame>
    <description>Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Mucopolysaccharidosis</condition>
  <condition>Fabry Disease</condition>
  <arm_group>
    <arm_group_label>mucopolysaccharidosis</arm_group_label>
    <description>mucopolysaccharidosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fabry disease</arm_group_label>
    <description>Fabry disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>healthy controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        25 eyes of MPS patients 25 eyes of Fabry patients 25 eyes of healthy age matched controls&#xD;
        (a difference of ± 5 years in the mean between both groups is accepted)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)&#xD;
&#xD;
          -  Fabry patients with cornea verticillata &gt; grade 1&#xD;
&#xD;
          -  Age ≥ 12 years&#xD;
&#xD;
          -  Patient is able to comply with the study procedure&#xD;
&#xD;
          -  Patient has consented to be in the trial&#xD;
&#xD;
          -  Ability to fixate a target&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of corneal transplantation or refractive surgery&#xD;
&#xD;
          -  Corneal pathologies other than MPS-associated corneal opacity&#xD;
&#xD;
          -  Corneal, conjunctival or intraocular inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanne Pitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology, University Medical Center, Johannes Gutenberg-</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology, University Medical Center, Johannes Gutenberg-</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Wasielica-Poslednik, MD</last_name>
      <phone>00496131173367</phone>
      <email>joanna.wasielica-poslednik@unimedizin-mainz.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>February 28, 2013</last_update_submitted>
  <last_update_submitted_qc>February 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Susanne Pitz</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Mucopolysaccharidosis</keyword>
  <keyword>Fabry disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fabry Disease</mesh_term>
    <mesh_term>Mucopolysaccharidoses</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/NCT01695161
org study id: MZ-MPS-2012-01
nct id: NCT01695161
lead sponsor: 
has dmc: No
The aim of the present study is to compare intraocular pressure (IOP) values assessed with
      Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann
      applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want
      to investigate biomechanical characteristics of the cornea and their influence on the
      IOP-measurements.
observational model: Case-Control
time perspective: Prospective
measure: agreement between ccIOP and GAT in MPS, Fabry and healthy controls
time frame: Sep 2013 (anticipated)
description: Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls
arm group label: mucopolysaccharidosis
description: mucopolysaccharidosis
arm group label: Fabry disease
description: Fabry disease
arm group label: healthy controls
description: healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susanne Pitz, MD
role: Principal Investigator
affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Susanne Pitz
investigator title: MD
mesh term: Fabry Disease
mesh term: Mucopolysaccharidoses