<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/NCT03791619</url>
  </required_header>
  <id_info>
    <org_study_id>TIOL-205-STPA</org_study_id>
    <nct_id>NCT03791619</nct_id>
  </id_info>
  <brief_title>Post-Approval Study of the TECNIS SYMFONY® Toric Lenses</brief_title>
  <acronym>ANCORA</acronym>
  <official_title>Post-Approval Study of the TECNIS SYMFONY® Toric Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Surgical Vision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Surgical Vision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative,&#xD;
      6-month clinical study conducted at up to 50 sites in the USA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">August 8, 2022</completion_date>
  <primary_completion_date type="Actual">August 8, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Bothersome Visual Symptoms</measure>
    <time_frame>6-month</time_frame>
    <description>The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Difficulty With an Activity Due to the Visual Symptoms</measure>
    <time_frame>6-month</time_frame>
    <description>The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">475</enrollment>
  <condition>Cataract</condition>
  <condition>Corneal Astigmatism</condition>
  <arm_group>
    <arm_group_label>Higher Cylinder Toric IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower Cylinder Toric IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Higher Cylinder Toric IOL</intervention_name>
    <description>Symfony Toric models ZXT300 and ZXT375 IOL</description>
    <arm_group_label>Higher Cylinder Toric IOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lower Cylinder Toric IOL</intervention_name>
    <description>Symfony Toric model ZXT150 IOL</description>
    <arm_group_label>Lower Cylinder Toric IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be at least 22 years old&#xD;
&#xD;
          -  have cataracts in both eyes&#xD;
&#xD;
          -  have a certain degree of astigmatism in at least one eye&#xD;
&#xD;
          -  sign the written informed consent&#xD;
&#xD;
          -  be willing and able to comply with examination procedures&#xD;
&#xD;
          -  understand, read and write English to complete informed consent and questionnaires&#xD;
&#xD;
          -  be available for study follow-up visits&#xD;
&#xD;
        Both eyes must qualify to be eligible to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in any other clinical study or have participated in a clinical&#xD;
             study during the last 30 days&#xD;
&#xD;
          -  Have a certain disease/illness such as poorly-controlled diabetes&#xD;
&#xD;
          -  Have certain ocular conditions such as uncontrolled glaucoma&#xD;
&#xD;
          -  Taking medication that may affect subject vision&#xD;
&#xD;
          -  Have irregular corneal astigmatism&#xD;
&#xD;
          -  Pregnant, plan to become pregnant during the study, or is breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Surgical Vision Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Surgical Vision</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Empire Eye &amp; Laser Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Eye Physicians &amp; Associates</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Eye Medical Group</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Eye Microsurgical Institute, Inc.</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Associates of Manatee</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levenson Eye Associates</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida Eye Surgeons, LLC dba Florida Eye Specialist</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center For Sight</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virdi Eye Clinic &amp; Laser Vision Care</name>
      <address>
        <city>Rock Island</city>
        <state>Illinois</state>
        <zip>61201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Eye Care &amp; Laser</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakland Ophthalmic Surgery</name>
      <address>
        <city>Birmingham</city>
        <state>Michigan</state>
        <zip>48009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekwani Vision Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern New Jersey Eye Institute PA</name>
      <address>
        <city>South Orange</city>
        <state>New Jersey</state>
        <zip>07079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwick Eye Center</name>
      <address>
        <city>Chambersburg</city>
        <state>Pennsylvania</state>
        <zip>17201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Cataract &amp; Laser Center</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memphis Eye &amp; Cataract Associates, PLLC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornea Associates of Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Eye &amp; Laser Center</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Focal Point Vision</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkhurst NuVision</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarus Eye Centre</name>
      <address>
        <city>Lacey</city>
        <state>Washington</state>
        <zip>98503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <results_first_submitted>July 7, 2023</results_first_submitted>
  <results_first_submitted_qc>August 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 29, 2023</results_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Astigmatism</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>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03791619/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>February 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03791619/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>It includes all subjects with ZXT300/375/150 toric IOL in the primary eye.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Higher Cylinder Group</title>
          <description>All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.</description>
        </group>
        <group group_id="P2">
          <title>Lower Cylinder Group</title>
          <description>All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="260"/>
                <participants group_id="P2" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="256"/>
                <participants group_id="P2" count="209"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Higher cylinder group consists of all subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. Lower cylinder group consists of all subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</population>
      <group_list>
        <group group_id="B1">
          <title>Higher Cylinder Group</title>
          <description>All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.</description>
        </group>
        <group group_id="B2">
          <title>Lower Cylinder Group</title>
          <description>All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</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="260"/>
            <count group_id="B2" value="215"/>
            <count group_id="B3" value="475"/>
          </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="69.2" spread="9.8"/>
                    <measurement group_id="B2" value="68.2" spread="7.9"/>
                    <measurement group_id="B3" value="68.7" spread="8.9"/>
                  </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="151"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="190"/>
                  </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="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </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="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Bothersome Visual Symptoms</title>
        <description>The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.</description>
        <time_frame>6-month</time_frame>
        <population>Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.</population>
        <group_list>
          <group group_id="O1">
            <title>Higher Cylinder Group</title>
            <description>All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.</description>
          </group>
          <group group_id="O2">
            <title>Lower Cylinder Group</title>
            <description>All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Bothersome Visual Symptoms</title>
          <description>The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.</description>
          <population>Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.</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="256"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Difficulty With an Activity Due to the Visual Symptoms</title>
        <description>The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.</description>
        <time_frame>6-month</time_frame>
        <population>Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.</population>
        <group_list>
          <group group_id="O1">
            <title>Higher Cylinder Group</title>
            <description>All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.</description>
          </group>
          <group group_id="O2">
            <title>Lower Cylinder Group</title>
            <description>All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Difficulty With an Activity Due to the Visual Symptoms</title>
          <description>The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.</description>
          <population>Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.</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="256"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Higher Cylinder Group</title>
          <description>All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.</description>
        </group>
        <group group_id="E2">
          <title>Lower Cylinder Group</title>
          <description>All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.</description>
        </group>
      </group_list>
      <serious_events>
        <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="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cystoid Macular Edema</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="260"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Vitreous Hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Undesirable Optical Phenomena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Elevated IOP requiring treatment</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="260"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Non-Ischemic Optic Neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Lens Axis Misalignment requiring SSI</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Retinal Detachment/Tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>RETINAL VEIN OCCLUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Visual Symptoms requiring SSI</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Tilt &amp; decentration requiring SSI</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>IOP Elevated Without Need for Treatment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Corneal Edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>IOP Greater than 10mmHg from Screening and More than 25mmHg</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="260"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Difficulty Breathing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Pneumonia/COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wrist Fracture Surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="12" subjects_at_risk="260"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Undesirable Optical Phenomena</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="260"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="215"/>
              </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>The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Luis Vargas, MD</name_or_title>
      <organization>Johnson &amp; Johnson Surgical Vision</organization>
      <phone>714-247-8200</phone>
      <email>LVarga17@its.jnj.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/NCT03791619
org study id: TIOL-205-STPA
nct id: NCT03791619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative,
      6-month clinical study conducted at up to 50 sites in the USA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of Bothersome Visual Symptoms
time frame: 6-month
description: The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
measure: Rate of Difficulty With an Activity Due to the Visual Symptoms
time frame: 6-month
description: The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
arm group label: Higher Cylinder Toric IOL
arm group type: Active Comparator
description: Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
arm group label: Lower Cylinder Toric IOL
arm group type: Active Comparator
description: Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
intervention type: Device
intervention name: Higher Cylinder Toric IOL
description: Symfony Toric models ZXT300 and ZXT375 IOL
arm group label: Higher Cylinder Toric IOL
intervention type: Device
intervention name: Lower Cylinder Toric IOL
description: Symfony Toric model ZXT150 IOL
arm group label: Lower Cylinder Toric IOL
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Johnson & Johnson Surgical Vision Clinical Trials
role: Study Director
affiliation: Johnson & Johnson Surgical Vision
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country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Astigmatism
sharing ipd: No
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