<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/NCT02228577</url>
  </required_header>
  <id_info>
    <org_study_id>TMI-14-01</org_study_id>
    <nct_id>NCT02228577</nct_id>
  </id_info>
  <brief_title>Safety and Performance Study of the CyPass System Applier Model 241</brief_title>
  <acronym>RePASS</acronym>
  <official_title>A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Transcend Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted&#xD;
      using the Model 241 Applier. The objective of this study is to characterize and evaluate the&#xD;
      safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular adverse events in the study eye</measure>
    <time_frame>Intraoperatively though the first 3 postoperative months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">172</enrollment>
  <condition>Open Angle Glaucoma (OAG)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with OAG who underwent combination cataract/glaucoma surgery and received the&#xD;
        CyPass Micro-Stent using the CyPass Applier Model 241&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of OAG&#xD;
&#xD;
          2. CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated&#xD;
             phacoemulsification cataract removal and intraocular lens implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or&#xD;
             neovascular glaucoma&#xD;
&#xD;
          2. Prior incisional glaucoma surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsontcho (Sean) Ianchulev, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Transcend Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum</name>
      <address>
        <city>Neubrandenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>May 12, 2017</last_update_submitted>
  <last_update_submitted_qc>May 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</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/NCT02228577
org study id: TMI-14-01
nct id: NCT02228577
lead sponsor: 
has dmc: No
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted
      using the Model 241 Applier. The objective of this study is to characterize and evaluate the
      safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.
observational model: Case-Only
time perspective: Retrospective
measure: Ocular adverse events in the study eye
time frame: Intraoperatively though the first 3 postoperative months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tsontcho (Sean) Ianchulev, MD, MPH
role: Study Chair
affiliation: Transcend Medical
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No