<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/NCT02203721</url>
  </required_header>
  <id_info>
    <org_study_id>EROV-106-ZXRC</org_study_id>
    <nct_id>NCT02203721</nct_id>
  </id_info>
  <brief_title>Clinical Investigation of a New Intraocular Lens</brief_title>
  <official_title>Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS&#xD;
      Symfony Extended Range of Vision IOL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance Corrected Intermediate Visual Acuity</measure>
    <time_frame>At 6 months</time_frame>
    <description>FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Uncorrected Intermediate Visual Acuity at 6 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">324</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>TECNIS Symfony Extended Range of Vision IOL, Model ZXR00</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TECNIS Monofocal IOL, Model ZCB00</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TECNIS Symfony Extended Range of Vision IOL, Model ZXR00</intervention_name>
    <arm_group_label>TECNIS Symfony Extended Range of Vision IOL, Model ZXR00</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TECNIS Monofocal IOL, Model ZCB00</intervention_name>
    <arm_group_label>TECNIS Monofocal IOL, Model ZCB00</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum 22 years of age&#xD;
&#xD;
          -  Bilateral cataracts for which phacoemulsification extraction and posterior IOL&#xD;
             implantation have been planned for both eyes&#xD;
&#xD;
          -  Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse&#xD;
             with or without a glare source&#xD;
&#xD;
          -  Potential for postoperative BCDVA of 20/30 Snellen or better&#xD;
&#xD;
          -  Corneal astigmatism&#xD;
&#xD;
          -  Clear intraocular media, other than cataract&#xD;
&#xD;
          -  Availability, willingness and sufficient cognitive awareness to comply with&#xD;
             examination procedures&#xD;
&#xD;
          -  Signed informed consent and HIPAA authorization&#xD;
&#xD;
          -  Ability to understand and respond to a questionnaire in English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D&#xD;
&#xD;
          -  Pupil abnormalities&#xD;
&#xD;
          -  Recent ocular trauma or ocular surgery that is not resolved/stable or may affect&#xD;
             visual outcomes or increase risk to the subject&#xD;
&#xD;
          -  Prior corneal refractive or intraocular surgery&#xD;
&#xD;
          -  Corneal abnormalities&#xD;
&#xD;
          -  Inability to achieve keratometric stability for contact lens wearers&#xD;
&#xD;
          -  Subjects with diagnosed degenerative visual disorders that are predicted to cause&#xD;
             visual acuity losses to a level of 20/30 Snellen or worse during the study&#xD;
&#xD;
          -  Subjects with conditions associated with increased risk of zonular rupture, including&#xD;
             capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as&#xD;
             pseudoexfoliation, trauma, or posterior capsule defects&#xD;
&#xD;
          -  Use of systemic or ocular medications that may affect vision&#xD;
&#xD;
          -  Prior, current, or anticipated use during the course of the 6-month study of&#xD;
             tamsulosin or silodosin, that may, in the opinion of the investigator, confound the&#xD;
             outcome or increase the risk to the subject&#xD;
&#xD;
          -  Inability to focus or fixate for prolonged periods of time&#xD;
&#xD;
          -  Poorly-controlled diabetes&#xD;
&#xD;
          -  Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the&#xD;
             opinion of the investigator, would increase the operative risk or confound the&#xD;
             outcome(s) of the study.&#xD;
&#xD;
          -  May be expected to require retinal laser treatment or other surgical intervention&#xD;
             during the course of the study&#xD;
&#xD;
          -  Patient is pregnant, plans to become pregnant, is lactating or has another condition&#xD;
             associated with the fluctuation of hormones that could lead to refractive changes&#xD;
&#xD;
          -  Concurrent participation or participation within 30 days prior to preoperative visit&#xD;
             in any other clinical trial&#xD;
&#xD;
          -  Desire for monovision correction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boozman-Hof Regional Eye Clinic</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Katzen Eye Care &amp; Laser Center</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Coral Eye Center</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virdi Eye Clinic &amp; Laser Vision Center</name>
      <address>
        <city>Rock Island</city>
        <state>Illinois</state>
        <zip>61201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Surgeons of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jones Eye Clinic</name>
      <address>
        <city>Sioux City</city>
        <state>Iowa</state>
        <zip>51104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Doctors of Washington</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Long Island</name>
      <address>
        <city>Rockville Center</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Center of Central PA</name>
      <address>
        <city>Allenwood</city>
        <state>Pennsylvania</state>
        <zip>17810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; Christie and Associates, PC</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loden Vision Center</name>
      <address>
        <city>Goodlettsville</city>
        <state>Tennessee</state>
        <zip>37072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitsett Vision Group</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Eye and Laser Center</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehmann Eye Center</name>
      <address>
        <city>Nacogdoches</city>
        <state>Texas</state>
        <zip>75965</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>September 28, 2016</results_first_submitted>
  <results_first_submitted_qc>November 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 11, 2017</results_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.</recruitment_details>
      <pre_assignment_details>A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TECNIS Intraocular Lens, Model ZXR00</title>
          <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
        </group>
        <group group_id="P2">
          <title>TECNIS Intraocular Lens, Model ZCB00</title>
          <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Illness</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TECNIS Intraocular Lens, Model ZXR00</title>
          <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
        </group>
        <group group_id="B2">
          <title>TECNIS Intraocular Lens, Model ZCB00</title>
          <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</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="148"/>
            <count group_id="B2" value="151"/>
            <count group_id="B3" value="299"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="68.0" spread="7.5"/>
                    <measurement group_id="B2" value="67.9" spread="7.9"/>
                    <measurement group_id="B3" value="67.9" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="91"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="122"/>
                  </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="148"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Distance Corrected Intermediate Visual Acuity</title>
        <description>FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.</description>
        <time_frame>At 6 months</time_frame>
        <population>Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>TECNIS Intraocular Lens, Model ZXR00</title>
            <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
          </group>
          <group group_id="O2">
            <title>TECNIS Intraocular Lens, Model ZCB00</title>
            <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Corrected Intermediate Visual Acuity</title>
          <description>FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.</description>
          <population>Intent to Treat Population</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.105" spread="0.009"/>
                    <measurement group_id="O2" value="0.343" spread="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Uncorrected Intermediate Visual Acuity</title>
        <description>Uncorrected Intermediate Visual Acuity at 6 months.</description>
        <time_frame>6 months</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>TECNIS Intraocular Lens, Model ZXR00</title>
            <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
          </group>
          <group group_id="O2">
            <title>TECNIS Intraocular Lens, Model ZCB00</title>
            <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Intermediate Visual Acuity</title>
          <description>Uncorrected Intermediate Visual Acuity at 6 months.</description>
          <population>Intent to Treat population</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.087" spread="0.009"/>
                    <measurement group_id="O2" value="0.258" spread="0.014"/>
                  </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>TECNIS Intraocular Lens, Model ZXR00</title>
          <description>Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00</description>
        </group>
        <group group_id="E2">
          <title>TECNIS Intraocular Lens, Model ZCB00</title>
          <description>Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cystoid Macular Edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pupillary Capture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypopyon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Epiretinal Membrane Peel</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Anterior Ischemic Optic Neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lens Fragment</sub_title>
                <description>Requiring fragment removal</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Anterior Basement Membrane Distrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <description>Requiring treatment injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kendra Hileman, Ph.D., Director of Clinical Research and Development</name_or_title>
      <organization>Abbott Medical Optics</organization>
      <phone>714-247-8613</phone>
      <email>kendra.hileman@abbott.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/NCT02203721
org study id: EROV-106-ZXRC
nct id: NCT02203721
lead sponsor: 
has dmc: No
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS
      Symfony Extended Range of Vision IOL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Distance Corrected Intermediate Visual Acuity
time frame: At 6 months
description: FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
measure: Uncorrected Intermediate Visual Acuity
time frame: 6 months
description: Uncorrected Intermediate Visual Acuity at 6 months.
arm group label: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
arm group type: Experimental
description: Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
arm group label: TECNIS Monofocal IOL, Model ZCB00
arm group type: Active Comparator
description: Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
intervention type: Device
intervention name: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
arm group label: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
intervention type: Device
intervention name: TECNIS Monofocal IOL, Model ZCB00
arm group label: TECNIS Monofocal IOL, Model ZCB00
criteria: 
gender: All
minimum age: 22 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 