<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/NCT03273907</url>
  </required_header>
  <id_info>
    <org_study_id>GLD122c-C001</org_study_id>
    <nct_id>NCT03273907</nct_id>
  </id_info>
  <brief_title>Post Approval Study of the CyPass System</brief_title>
  <official_title>Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</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 purpose of this study is to demonstrate that the rate of clinically relevant&#xD;
      complications associated with CyPass Micro-Stent placement and stability using the CyPass&#xD;
      241-S applier, as determined at 36 months in the postmarket setting, is less than the&#xD;
      pre-specified performance target, which is based on experience with the CyPass Model E&#xD;
      applier in COMPASS trial TMI-09-01 (NCT01085357).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject's expected participation in the study is up to 37.5 months which includes up to&#xD;
      42 days between the screening and surgery visits, and 36 months of post-surgery follow-up.&#xD;
      Only one eye per subject will be implanted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Voluntary market withdrawal&#xD;
  </why_stopped>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36</measure>
    <time_frame>Up to Month 36 postoperative</time_frame>
    <description>Device-related complications, as specified in the protocol, included:&#xD;
Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.&#xD;
Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:&#xD;
The device is not in the supraciliary space, or&#xD;
There is a clinical sequela resulting from device position including, but not limited to:&#xD;
Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)&#xD;
Corneal endothelial touch by device&#xD;
Corneal edema leading to loss of BCDVA &gt; 2 lines at the last postoperative visit, in comparison with preoperative BCDVA&#xD;
Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in IOP From Baseline at Month 36</measure>
    <time_frame>Baseline, Month 36 postoperative</time_frame>
    <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36</measure>
    <time_frame>Baseline, Month 36 postoperative</time_frame>
    <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36</measure>
    <time_frame>Month 36 postoperative</time_frame>
    <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Sight-threatening Adverse Events (AEs)</measure>
    <time_frame>Up to Month 36 postoperative</time_frame>
    <description>Sight-threatening adverse events, as specified in the protocol, included:&#xD;
Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more&#xD;
Endophthalmitis&#xD;
Corneal decompensation&#xD;
Retinal detachment&#xD;
Severe choroidal hemorrhage or detachment&#xD;
Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)</measure>
    <time_frame>Up to Month 36 postoperative</time_frame>
    <description>A secondary surgical intervention may have occurred for any of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
CyPass device explantation NOT associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol).&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability</measure>
    <time_frame>Up to Month 36 postoperative</time_frame>
    <description>A secondary surgical intervention may have occurred for either of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability.&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Primary Open-angle Glaucoma</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>CyPass System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CyPass Micro-Stent implanted with CyPass 241-S applier</intervention_name>
    <description>CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.</description>
    <arm_group_label>CyPass System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit</description>
    <arm_group_label>CyPass System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand the requirements of the study and willing to follow study&#xD;
             instructions, provide written informed consent, and agree to comply with all study&#xD;
             requirements, including the required study follow-up visits&#xD;
&#xD;
          -  Diagnosis of primary open angle glaucoma (POAG)&#xD;
&#xD;
          -  Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg,&#xD;
             or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg&#xD;
&#xD;
          -  An operable age-related cataract eligible for phacoemulsification&#xD;
&#xD;
          -  Visual acuity as specified in the protocol&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to complete a visual field test prior to surgery&#xD;
&#xD;
          -  Use of ocular hypotensive medication/s, as specified in the protocol&#xD;
&#xD;
          -  Diagnosis of glaucoma other than POAG, as specified in the protocol&#xD;
&#xD;
          -  Other medical conditions, as specified in the protocol&#xD;
&#xD;
          -  Proliferative diabetic retinopathy&#xD;
&#xD;
          -  Previous surgery for retinal detachment&#xD;
&#xD;
          -  Previous corneal surgery&#xD;
&#xD;
          -  Wet age-related macular degeneration&#xD;
&#xD;
          -  Poor vision in the non-study eye not due to cataract&#xD;
&#xD;
          -  Significant ocular inflammation or infection within 30 days of screening visit&#xD;
&#xD;
          -  Uncontrolled systemic diseases that may put the subject's health at risk and/or&#xD;
             prevent the subject from completing all study visits&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  Other protocol-specified exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sr. Clinical Trial Lead, Surgical</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Garden City</city>
        <state>Kansas</state>
        <zip>67846</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Fraser</city>
        <state>Michigan</state>
        <zip>48026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investivative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Vineland</city>
        <state>New Jersey</state>
        <zip>08361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Chambersburg</city>
        <state>Pennsylvania</state>
        <zip>17201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004-3012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>August 24, 2022</results_first_submitted>
  <results_first_submitted_qc>August 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2022</results_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CyPass Micro-Stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03273907/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03273907/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 20 investigative sites located in the United States.&#xD;
Due to the CyPass voluntary global market withdrawal, enrollment was permanently suspended for this study starting 29 August 2018.</recruitment_details>
      <pre_assignment_details>Of the 79 enrolled, 36 subjects were exited from the study prior to attempted implantation with the CyPass Micro-Stent. This reporting group includes all subjects/eyes with attempted implantation (43).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CyPass System</title>
          <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID 19</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat Analysis Set: All study eyes for which a CyPass Micro-Stent implant was attempted</population>
      <group_list>
        <group group_id="B1">
          <title>CyPass System</title>
          <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.4" spread="5.31"/>
                  </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="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36</title>
        <description>Device-related complications, as specified in the protocol, included:&#xD;
Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.&#xD;
Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:&#xD;
The device is not in the supraciliary space, or&#xD;
There is a clinical sequela resulting from device position including, but not limited to:&#xD;
Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)&#xD;
Corneal endothelial touch by device&#xD;
Corneal edema leading to loss of BCDVA &gt; 2 lines at the last postoperative visit, in comparison with preoperative BCDVA&#xD;
Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up)</description>
        <time_frame>Up to Month 36 postoperative</time_frame>
        <population>Intent-to-Treat (ITT) Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36</title>
          <description>Device-related complications, as specified in the protocol, included:&#xD;
Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.&#xD;
Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:&#xD;
The device is not in the supraciliary space, or&#xD;
There is a clinical sequela resulting from device position including, but not limited to:&#xD;
Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)&#xD;
Corneal endothelial touch by device&#xD;
Corneal edema leading to loss of BCDVA &gt; 2 lines at the last postoperative visit, in comparison with preoperative BCDVA&#xD;
Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up)</description>
          <population>Intent-to-Treat (ITT) Analysis Set</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.</non_inferiority_desc>
            <p_value>0.1870</p_value>
            <method>Exact one-sided binomial test</method>
            <method_desc>P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in IOP From Baseline at Month 36</title>
        <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.</description>
        <time_frame>Baseline, Month 36 postoperative</time_frame>
        <population>ITT Analysis Set with data at visit</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in IOP From Baseline at Month 36</title>
          <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.</description>
          <population>ITT Analysis Set with data at visit</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.71" spread="4.881"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36</title>
        <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.</description>
        <time_frame>Baseline, Month 36 postoperative</time_frame>
        <population>ITT Analysis Set with data at visit</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36</title>
          <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.</description>
          <population>ITT Analysis Set with data at visit</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="24.6" upper_limit="59.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36</title>
        <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg).</description>
        <time_frame>Month 36 postoperative</time_frame>
        <population>ITT Analysis Set with data at visit</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36</title>
          <description>Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg).</description>
          <population>ITT Analysis Set with data at visit</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8" lower_limit="43.6" upper_limit="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Sight-threatening Adverse Events (AEs)</title>
        <description>Sight-threatening adverse events, as specified in the protocol, included:&#xD;
Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more&#xD;
Endophthalmitis&#xD;
Corneal decompensation&#xD;
Retinal detachment&#xD;
Severe choroidal hemorrhage or detachment&#xD;
Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.</description>
        <time_frame>Up to Month 36 postoperative</time_frame>
        <population>ITT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Sight-threatening Adverse Events (AEs)</title>
          <description>Sight-threatening adverse events, as specified in the protocol, included:&#xD;
Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more&#xD;
Endophthalmitis&#xD;
Corneal decompensation&#xD;
Retinal detachment&#xD;
Severe choroidal hemorrhage or detachment&#xD;
Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.</description>
          <population>ITT Analysis Set</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.1" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)</title>
        <description>A secondary surgical intervention may have occurred for any of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
CyPass device explantation NOT associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol).&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
        <time_frame>Up to Month 36 postoperative</time_frame>
        <population>ITT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)</title>
          <description>A secondary surgical intervention may have occurred for any of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
CyPass device explantation NOT associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol).&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
          <population>ITT Analysis Set</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="1.5" upper_limit="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability</title>
        <description>A secondary surgical intervention may have occurred for either of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability.&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
        <time_frame>Up to Month 36 postoperative</time_frame>
        <population>ITT Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CyPass System</title>
            <description>CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability</title>
          <description>A secondary surgical intervention may have occurred for either of the following reasons:&#xD;
CyPass device explantation associated with CyPass placement and stability&#xD;
Unplanned ocular surgical reintervention associated with CyPass placement and stability.&#xD;
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE</description>
          <population>ITT Analysis Set</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.1" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.</time_frame>
      <desc>This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). &quot;At Risk&quot; population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pretreatment</title>
          <description>Events reported in this group occurred prior to attempted implantation with the test article</description>
        </group>
        <group group_id="E2">
          <title>CyPass Study Eye</title>
          <description>Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye</description>
        </group>
        <group group_id="E3">
          <title>CyPass Systemic</title>
          <description>Events reported in this group occurred after attempted implantation with the test article and exclude ocular events in the study eye</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Paracentesis eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Throat cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Glaucoma drainage device placement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="43"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Considering the achieved sample size in this study (less than 10% of intended), no definitive conclusion can be made with respect to the rate of CyPass-related complications.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>CDMA Clinical Lead, Surgical</name_or_title>
      <organization>Alcon Research, LLC</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.com</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/NCT03273907
org study id: GLD122c-C001
nct id: NCT03273907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to demonstrate that the rate of clinically relevant
      complications associated with CyPass Micro-Stent placement and stability using the CyPass
      241-S applier, as determined at 36 months in the postmarket setting, is less than the
      pre-specified performance target, which is based on experience with the CyPass Model E
      applier in COMPASS trial TMI-09-01 (NCT01085357).
Each subject's expected participation in the study is up to 37.5 months which includes up to
      42 days between the screening and surgery visits, and 36 months of post-surgery follow-up.
      Only one eye per subject will be implanted.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
time frame: Up to Month 36 postoperative
description: Device-related complications, as specified in the protocol, included:
Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.
Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:
The device is not in the supraciliary space, or
There is a clinical sequela resulting from device position including, but not limited to:
Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)
Corneal endothelial touch by device
Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA
Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up)
measure: Mean Change in IOP From Baseline at Month 36
time frame: Baseline, Month 36 postoperative
description: Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement.
measure: Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36
time frame: Baseline, Month 36 postoperative
description: Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.
measure: Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36
time frame: Month 36 postoperative
description: Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg).
measure: Percentage of Eyes With Sight-threatening Adverse Events (AEs)
time frame: Up to Month 36 postoperative
description: Sight-threatening adverse events, as specified in the protocol, included:
Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more
Endophthalmitis
Corneal decompensation
Retinal detachment
Severe choroidal hemorrhage or detachment
Aqueous misdirection. Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE.
measure: Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)
time frame: Up to Month 36 postoperative
description: A secondary surgical intervention may have occurred for any of the following reasons:
CyPass device explantation associated with CyPass placement and stability
CyPass device explantation NOT associated with CyPass placement and stability
Unplanned ocular surgical reintervention associated with CyPass placement and stability
Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol).
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE
measure: Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability
time frame: Up to Month 36 postoperative
description: A secondary surgical intervention may have occurred for either of the following reasons:
CyPass device explantation associated with CyPass placement and stability
Unplanned ocular surgical reintervention associated with CyPass placement and stability.
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE
arm group label: CyPass System
arm group type: Experimental
description: CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
intervention type: Device
intervention name: CyPass Micro-Stent implanted with CyPass 241-S applier
description: CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.
arm group label: CyPass System
intervention type: Procedure
intervention name: Cataract surgery
description: Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
arm group label: CyPass System
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. Clinical Trial Lead, Surgical
role: Study Director
affiliation: Alcon Research, LLC
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country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Considering the achieved sample size in this study (less than 10% of intended), no definitive conclusion can be made with respect to the rate of CyPass-related complications.
point of contact: 