<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/NCT04454138</url>
  </required_header>
  <id_info>
    <org_study_id>955</org_study_id>
    <nct_id>NCT04454138</nct_id>
  </id_info>
  <brief_title>Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement</brief_title>
  <official_title>Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prism Eye Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Prism Eye Institute</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS).&#xD;
      Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery),&#xD;
      the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to&#xD;
      fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a&#xD;
      surgery known as supra-tenon's space is believed to maximize aqueous outflow, while&#xD;
      preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
      Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's&#xD;
      placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming&#xD;
      microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and&#xD;
      under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow&#xD;
      pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of&#xD;
      failure to trabeculectomy. Amongst the main advantages of this device is the ability to&#xD;
      create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound&#xD;
      healing and potentially limiting bleb failure. However, despite demonstrating similar&#xD;
      efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer&#xD;
      from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of&#xD;
      the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound&#xD;
      healing that can result following surgery, fibrosis may still occur, especially when the&#xD;
      components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic&#xD;
      structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple&#xD;
      adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN&#xD;
      within this space creates a higher risk of obstruction and subsequent failure. To ensure the&#xD;
      lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement&#xD;
      of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in&#xD;
      the supra-tenon's space is believed to maximize aqueous outflow, while preventing&#xD;
      obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the&#xD;
      theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is&#xD;
      needed to fully assess its potential in improving Xen-45 microstent outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.</measure>
    <time_frame>Post op year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.</measure>
    <time_frame>Post op Year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.</measure>
    <time_frame>Post op year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.</measure>
    <time_frame>Post op Year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.</measure>
    <time_frame>Post op Year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.</measure>
    <time_frame>Post op year 1</time_frame>
    <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</measure>
    <time_frame>Post op year 1</time_frame>
    <description>Presence or absence of the following complications:&#xD;
i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia.&#xD;
ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</measure>
    <time_frame>Post op year 1</time_frame>
    <description>Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">142</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Targeted supratenon's placement of XEN 45</arm_group_label>
    <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-targeted placement of XEN 45</arm_group_label>
    <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XEN-45 gelatin microstent</intervention_name>
    <description>Placement either in the subconjunctival space or supratenon's area</description>
    <arm_group_label>Non-targeted placement of XEN 45</arm_group_label>
    <arm_group_label>Targeted supratenon's placement of XEN 45</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary&#xD;
        closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated&#xD;
        medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012&#xD;
        to August 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary&#xD;
             closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum&#xD;
             tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute&#xD;
             from June 2012 to August 2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other forms of glaucoma&#xD;
&#xD;
          -  Prior incisional glaucoma surgery&#xD;
&#xD;
          -  CPC&#xD;
&#xD;
          -  Prior corneal graft (PKP, DALK, DSAEK, DMEK).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iqbal Ike Ahmed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prism Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prism Eye Institute</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6H 0J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.</citation>
    <PMID>28237137</PMID>
  </reference>
  <reference>
    <citation>Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7. Erratum In: Ophthalmology. 2018 Mar;125(3):463.</citation>
    <PMID>28601250</PMID>
  </reference>
  <reference>
    <citation>Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.</citation>
    <PMID>28751986</PMID>
  </reference>
  <reference>
    <citation>Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.</citation>
    <PMID>29053204</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <results_first_submitted>July 3, 2020</results_first_submitted>
  <results_first_submitted_qc>July 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2020</results_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prism Eye Institute</investigator_affiliation>
    <investigator_full_name>Iqbal Ahmed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT04454138/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-targeted Placement of XEN 45</title>
          <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
        <group group_id="P2">
          <title>Targeted Supratenon's Placement of XEN 45</title>
          <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-targeted Placement of XEN 45</title>
          <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
        <group group_id="B2">
          <title>Targeted Supratenon's Placement of XEN 45</title>
          <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="65"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="142"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.4" lower_limit="55.8" upper_limit="71.6"/>
                    <measurement group_id="B2" value="78" lower_limit="70" upper_limit="83.6"/>
                    <measurement group_id="B3" value="70.9" lower_limit="55.8" upper_limit="83.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative Best Corrected Visual Acuity (BCVA)</title>
          <units>logMAR</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                    <measurement group_id="B2" value="0.3" lower_limit="0.2" upper_limit="0.5"/>
                    <measurement group_id="B3" value="0.2" lower_limit="0.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Patients who received XEN 45 in Left Eye</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IOP &gt; 21 mmHg</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IOP median</title>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21" lower_limit="18" upper_limit="27.5"/>
                    <measurement group_id="B2" value="22" lower_limit="19.5" upper_limit="26"/>
                    <measurement group_id="B3" value="21" lower_limit="18" upper_limit="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication Classes</title>
          <units>Medication Classes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="B2" value="4" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B3" value="4" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Open Angle Glaucoma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pseudoexfoliation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pigment Dispersion Glaucoma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Angle Closure Glaucoma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Combined Mechanism Glaucoma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cup to Disk Ratio</title>
          <units>Ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.9" lower_limit="0.8" upper_limit="0.9"/>
                    <measurement group_id="B2" value="0.8" lower_limit="0.7" upper_limit="0.9"/>
                    <measurement group_id="B3" value="0.8" lower_limit="0.7" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative Mean Deviation on Visual Field to Normal Population</title>
          <units>decibel</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-8.4" lower_limit="-14.1" upper_limit="-4.2"/>
                    <measurement group_id="B2" value="-1.7" lower_limit="-8" upper_limit="0"/>
                    <measurement group_id="B3" value="-4" lower_limit="-14.1" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mild Disease</title>
          <description>0 to &gt;-6.0 dB mean deviation from normal in visual fields</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Moderate to Severe Disease</title>
          <description>≤-6.0 dB mean deviation from normal visual fields</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Laser Peripheral Iridotomy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Laser Trabeculoplasty</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Cataract Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications</description>
        <time_frame>Post op year 1</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications</description>
          <population>Per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications</description>
        <time_frame>Post op Year 1</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications</description>
          <population>Per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications</description>
        <time_frame>Post op year 1</time_frame>
        <population>Per protocol polulation</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications</description>
          <population>Per protocol polulation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication</description>
        <time_frame>Post op Year 1</time_frame>
        <population>per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication</description>
          <population>per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications</description>
        <time_frame>Post op Year 1</time_frame>
        <population>per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications</description>
          <population>per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.</title>
        <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications</description>
        <time_frame>Post op year 1</time_frame>
        <population>per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.</title>
          <description>Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications</description>
          <population>per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</title>
        <description>Presence or absence of the following complications:&#xD;
i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia.&#xD;
ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis</description>
        <time_frame>Post op year 1</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</title>
          <description>Presence or absence of the following complications:&#xD;
i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia.&#xD;
ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis</description>
          <population>Per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</title>
        <description>Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.</description>
        <time_frame>Post op year 1</time_frame>
        <population>per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-targeted Placement of XEN 45</title>
            <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
          <group group_id="O2">
            <title>Targeted Supratenon's Placement of XEN 45</title>
            <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.</title>
          <description>Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.</description>
          <population>per protocol population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-targeted Placement of XEN 45</title>
          <description>Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
        <group group_id="E2">
          <title>Targeted Supratenon's Placement of XEN 45</title>
          <description>Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.&#xD;
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ronaldo Santiago</name_or_title>
      <organization>Prism Eye Institute</organization>
      <phone>905-456-3937 ext 267</phone>
      <email>ronaldo.santiago@prismeye.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04454138
org study id: 955
nct id: NCT04454138
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS).
      Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery),
      the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to
      fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a
      surgery known as supra-tenon's space is believed to maximize aqueous outflow, while
      preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
      Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's
      placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.
The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming
      microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and
      under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow
      pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of
      failure to trabeculectomy. Amongst the main advantages of this device is the ability to
      create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound
      healing and potentially limiting bleb failure. However, despite demonstrating similar
      efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer
      from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of
      the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound
      healing that can result following surgery, fibrosis may still occur, especially when the
      components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic
      structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple
      adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN
      within this space creates a higher risk of obstruction and subsequent failure. To ensure the
      lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement
      of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in
      the supra-tenon's space is believed to maximize aqueous outflow, while preventing
      obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the
      theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is
      needed to fully assess its potential in improving Xen-45 microstent outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.
time frame: Post op year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.
time frame: Post op Year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.
time frame: Post op year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.
time frame: Post op Year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.
time frame: Post op Year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications
measure: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.
time frame: Post op year 1
description: Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications
measure: Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
time frame: Post op year 1
description: Presence or absence of the following complications:
i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia.
ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis
measure: Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
time frame: Post op year 1
description: Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.
arm group label: Targeted supratenon's placement of XEN 45
description: Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
arm group label: Non-targeted placement of XEN 45
description: Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
intervention type: Device
intervention name: XEN-45 gelatin microstent
description: Placement either in the subconjunctival space or supratenon's area
arm group label: Non-targeted placement of XEN 45
arm group label: Targeted supratenon's placement of XEN 45
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
last name: Iqbal Ike Ahmed, MD
role: Principal Investigator
affiliation: Prism Eye Institute
facility: 
country: Canada
citation: Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.
PMID: 28237137
citation: Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7. Erratum In: Ophthalmology. 2018 Mar;125(3):463.
PMID: 28601250
citation: Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.
PMID: 28751986
citation: Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.
PMID: 29053204
responsible party type: Principal Investigator
investigator affiliation: Prism Eye Institute
investigator full name: Iqbal Ahmed
investigator title: Principal Investigator
mesh term: Glaucoma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 