<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/NCT03771274</url>
  </required_header>
  <id_info>
    <org_study_id>CEP18-002</org_study_id>
    <nct_id>NCT03771274</nct_id>
  </id_info>
  <brief_title>Tecnis ZLB00 &amp; Symfony Intraocular Lens Combination Outcomes</brief_title>
  <official_title>Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carolina Eyecare Physicians, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Science in Vision</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johnson &amp; Johnson Surgical Vision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Carolina Eyecare Physicians, LLC</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>
      Current visual outcomes expectations of cataract patients are similar to those of refractive&#xD;
      surgery patients. Their desire is to be spectacle independent for far, intermediate and near&#xD;
      vision activities. Some may have already enjoyed freedom from glasses and would like to&#xD;
      continue after the cataracts are removed. Different options are available. These options&#xD;
      include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia&#xD;
      correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs.&#xD;
      In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes&#xD;
      were targeted for plano and when the non-dominant eye was set for a small residual myopic&#xD;
      error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared&#xD;
      to provide similar binocular acuity at distance and intermediate but better acuity at near.&#xD;
      The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined&#xD;
      with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing&#xD;
      routine cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Binocular Uncorrected Near (40 cm) Visual Acuity.</measure>
    <time_frame>3 months</time_frame>
    <description>Visual acuity measured at 40 cm without wearing any correction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Visual Satisfaction After Cataract Surgery: Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: &quot;Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision&quot;. Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spectacle Independence: Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patient's spectacle independence was assessed using the &quot;Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Visual Symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Cataract Bilateral</condition>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Tecnis ZLB00 &amp; Symfony IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tecnis ZLB00 &amp; Symfony IOL</intervention_name>
    <description>The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
    <arm_group_label>Tecnis ZLB00 &amp; Symfony IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is undergoing bilateral cataract extraction with intraocular lens&#xD;
             implantation.&#xD;
&#xD;
          2. Willing and able to provide written informed consent for participation in the study&#xD;
&#xD;
          3. Willing and able to comply with scheduled visits and other study procedures.&#xD;
&#xD;
          4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes&#xD;
             within 6-15 days between surgeries.&#xD;
&#xD;
          5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.&#xD;
&#xD;
          6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both&#xD;
             eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication for a presbyopia correcting IOL.&#xD;
&#xD;
          2. Subjects with severe astigmatism in the non-dominant eye&#xD;
&#xD;
          3. Uncontrolled diabetes.&#xD;
&#xD;
          4. Use of any systemic or topical drug known to interfere with visual performance.&#xD;
&#xD;
          5. Contact lens use during the active treatment portion of the trial.&#xD;
&#xD;
          6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.&#xD;
&#xD;
          7. Clinically significant corneal dystrophy&#xD;
&#xD;
          8. History of chronic intraocular inflammation.&#xD;
&#xD;
          9. History of retinal detachment.&#xD;
&#xD;
         10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the&#xD;
             zonules.&#xD;
&#xD;
         11. Previous intraocular surgery.&#xD;
&#xD;
         12. Previous refractive surgery.&#xD;
&#xD;
         13. Previous keratoplasty&#xD;
&#xD;
         14. Severe dry eye&#xD;
&#xD;
         15. Pupil abnormalities&#xD;
&#xD;
         16. Subject who may reasonably be expected to require a secondary surgical intervention at&#xD;
             any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e.&#xD;
             LASIK)&#xD;
&#xD;
         17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).&#xD;
&#xD;
         18. Any clinically significant, serious or severe medical or psychiatric condition that&#xD;
             may increase the risk associated with study participation or may interfere with the&#xD;
             interpretation of study results.&#xD;
&#xD;
         19. Participation in (or current participation) any ophthalmic investigational drug or&#xD;
             ophthalmic device trial within the previous 30 days prior to the start date of this&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carolina Eyecare Physicians, LLC</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>July 14, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2020</results_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</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>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03771274/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tecnis ZLB00 &amp; Symfony IOL</title>
          <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant 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="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tecnis ZLB00 &amp; Symfony IOL</title>
          <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </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="65.7" spread="6.2"/>
                  </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="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Binocular Uncorrected Near (40 cm) Visual Acuity.</title>
        <description>Visual acuity measured at 40 cm without wearing any correction.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tecnis ZLB00 &amp; Symfony IOL</title>
            <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Uncorrected Near (40 cm) Visual Acuity.</title>
          <description>Visual acuity measured at 40 cm without wearing any correction.</description>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Visual Satisfaction After Cataract Surgery: Questionnaire</title>
        <description>Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: &quot;Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision&quot;. Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tecnis ZLB00 &amp; Symfony IOL</title>
            <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Visual Satisfaction After Cataract Surgery: Questionnaire</title>
          <description>Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: &quot;Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision&quot;. Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Completely or mostly satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little or not satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spectacle Independence: Questionnaire</title>
        <description>Patient's spectacle independence was assessed using the &quot;Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tecnis ZLB00 &amp; Symfony IOL</title>
            <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Spectacle Independence: Questionnaire</title>
          <description>Patient's spectacle independence was assessed using the &quot;Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Visual Symptoms</title>
        <description>Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tecnis ZLB00 &amp; Symfony IOL</title>
            <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Visual Symptoms</title>
          <description>Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Halos : Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Halos : No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity to light: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity to light: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 to 5 months</time_frame>
      <desc>Adverse events were collected from the moment participant signed the informed consent until he or she exited the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tecnis ZLB00 &amp; Symfony IOL</title>
          <description>The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.&#xD;
Tecnis ZLB00 &amp; Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Research</name_or_title>
      <organization>Carolina Eyecare Physicians, LLC</organization>
      <phone>8438813937</phone>
      <email>helga.sandoval@carolinaeyecare.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/NCT03771274
org study id: CEP18-002
nct id: NCT03771274
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Current visual outcomes expectations of cataract patients are similar to those of refractive
      surgery patients. Their desire is to be spectacle independent for far, intermediate and near
      vision activities. Some may have already enjoyed freedom from glasses and would like to
      continue after the cataracts are removed. Different options are available. These options
      include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia
      correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs.
      In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes
      were targeted for plano and when the non-dominant eye was set for a small residual myopic
      error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared
      to provide similar binocular acuity at distance and intermediate but better acuity at near.
      The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined
      with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing
      routine cataract surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Binocular Uncorrected Near (40 cm) Visual Acuity.
time frame: 3 months
description: Visual acuity measured at 40 cm without wearing any correction.
measure: Patient Visual Satisfaction After Cataract Surgery: Questionnaire
time frame: 3 months
description: Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.
measure: Spectacle Independence: Questionnaire
time frame: 3 months
description: Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.
measure: Number of Participants With Visual Symptoms
time frame: 3 months
description: Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.
arm group label: Tecnis ZLB00 & Symfony IOL
arm group type: Experimental
description: The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.
intervention type: Device
intervention name: Tecnis ZLB00 & Symfony IOL
description: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
arm group label: Tecnis ZLB00 & Symfony IOL
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Presbyopia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 