<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/NCT04406467</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00201210</org_study_id>
    <secondary_id>133133</secondary_id>
    <nct_id>NCT04406467</nct_id>
  </id_info>
  <brief_title>Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach</brief_title>
  <official_title>Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To measure surgical success of open vs closed conjunctiva with Xen implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective, single-arm multicenter study included &gt;100 eyes (&gt;100 patients) with&#xD;
      glaucoma refractory to medical therapy. All surgeries were performed by two groups of&#xD;
      surgeons at Johns Hopkins University and the sub-investigator group at New York University.&#xD;
      Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was&#xD;
      placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno&#xD;
      or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or&#xD;
      application of mitomycin-C.&#xD;
&#xD;
      Success rates will be determined based on need for re-intervention and intraocular pressure&#xD;
      control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2017</start_date>
  <completion_date type="Actual">August 26, 2020</completion_date>
  <primary_completion_date type="Actual">August 26, 2020</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>re-intervention rate</measure>
    <time_frame>3 months</time_frame>
    <description>This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in intraocular pressure</measure>
    <time_frame>1 day, 1 week, 1 month and 3 months</time_frame>
    <description>will be assessed as a % change in intraocular pressure</description>
  </secondary_outcome>
  <enrollment type="Actual">137</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xen Gel Stent</intervention_name>
    <description>Ab-interno or Ab-Externa Xen with closed or open conjunctiva.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the two institutions with elevated IOP and required surgery to lower&#xD;
        IOP.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Require surgery for uncontrolled glaucoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins Univeristy</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.</citation>
    <PMID>32200534</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma surgery</keyword>
  <keyword>Xen Gel Stent</keyword>
  <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>
    <ipd_description>De-identified internal use data.</ipd_description>
  </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/NCT04406467
org study id: IRB00201210
secondary id: 133133
nct id: NCT04406467
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To measure surgical success of open vs closed conjunctiva with Xen implantation.
This retrospective, single-arm multicenter study included >100 eyes (>100 patients) with
      glaucoma refractory to medical therapy. All surgeries were performed by two groups of
      surgeons at Johns Hopkins University and the sub-investigator group at New York University.
      Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was
      placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno
      or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or
      application of mitomycin-C.

      Success rates will be determined based on need for re-intervention and intraocular pressure
      control.
observational model: Case-Only
time perspective: Retrospective
measure: re-intervention rate
time frame: 3 months
description: This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation
measure: Change in intraocular pressure
time frame: 1 day, 1 week, 1 month and 3 months
description: will be assessed as a % change in intraocular pressure
intervention type: Device
intervention name: Xen Gel Stent
description: Ab-interno or Ab-Externa Xen with closed or open conjunctiva.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.
PMID: 32200534
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No
ipd description: De-identified internal use data.