<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/NCT04482439</url>
  </required_header>
  <id_info>
    <org_study_id>TN-20-001</org_study_id>
    <nct_id>NCT04482439</nct_id>
  </id_info>
  <brief_title>Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye</brief_title>
  <official_title>Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newsom Eye &amp; Laser Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Newsom Eye &amp; Laser Center</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>
      The objective is to assess binocular distance-corrected near (40 cm) visual acuity of&#xD;
      patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity&#xD;
      Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected&#xD;
      near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after&#xD;
      successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively&#xD;
      and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include&#xD;
      administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle&#xD;
      independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as&#xD;
      measurement of bilateral visual acuity and manifest refraction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">June 10, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Binocular Near Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prediction Accuracy</measure>
    <time_frame>3 months postop</time_frame>
    <description>Percentage of eyes with postoperative refractive accuracy within 0.5D of target</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spectacle Independence</measure>
    <time_frame>3 months postop</time_frame>
    <description>Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - &quot;a little of the time&quot; or &quot;none of the time&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Spectacle Independence</measure>
    <time_frame>3 months postop</time_frame>
    <description>Patients reporting rarely or never needing glasses overall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Rating Frequency of Visual Disturbances as &quot;Never&quot; or &quot;Rarely&quot;</measure>
    <time_frame>3 months postop</time_frame>
    <description>This is the frequency of subjects responding, &quot;Never&quot; or &quot;Rarely&quot; to a question about the frequency of glare, halos and starbursts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manifest Refraction</measure>
    <time_frame>3 months postop</time_frame>
    <description>Manifest refraction (residual spherical equivalent refraction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Cylinder</measure>
    <time_frame>3 months</time_frame>
    <description>Residual refractive cylinder after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Distance Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Bilateral uncorrected distance visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Bilateral uncorrected visual acuity at 66 cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Near Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Bilateral uncorrected near visual acuity at 40 cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected Distance Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Bliateral corrected distance visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance Corrected Intermediate Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Bliateral distance corrected visual acuity at 66 cm</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Vivity mini-monovision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vivity Extended Depth of Focus intraocular lens (IOL)</intervention_name>
    <description>Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.</description>
    <arm_group_label>Vivity mini-monovision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Presenting for uncomplicated bilateral cataract surgery and have an interest in&#xD;
             spectacle independence using an EDF IOL&#xD;
&#xD;
               -  Meet the requirements for on-label implantation of the EDF IOL&#xD;
&#xD;
               -  Gender: Males and Females.&#xD;
&#xD;
               -  Age: 40 or older.&#xD;
&#xD;
               -  Willing and able to provide written informed consent for participation in the&#xD;
                  study.&#xD;
&#xD;
               -  Willing and able to comply with scheduled visits and other study procedures.&#xD;
&#xD;
               -  Have good ocular health, with no pathology that compromises visual acuity&#xD;
                  (outside of residual refractive error and cataract)&#xD;
&#xD;
               -  Have regular corneal astigmatism with a magnitude that can be treated with a&#xD;
                  non-toric IOL or toric IOL.&#xD;
&#xD;
               -  Have 20/32 (0.2 logMAR) or better potential acuity in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Irregular astigmatism (e.g. keratoconus)&#xD;
&#xD;
               -  Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)&#xD;
&#xD;
               -  Monocular status (e.g. amblyopia)&#xD;
&#xD;
               -  Previous radial keratotomy, corneal refractive surgery or other corneal surgery&#xD;
                  (e.g. corneal transplant, DSAEK, lamellar keratoplasty)&#xD;
&#xD;
               -  Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser&#xD;
                  iridotomy)&#xD;
&#xD;
               -  Diabetic retinopathy&#xD;
&#xD;
               -  Macular pathology (e.g. ARMD, ERM)&#xD;
&#xD;
               -  History of retinal detachment&#xD;
&#xD;
               -  Subjects who have an unstable acute or chronic disease or illness that would&#xD;
                  confound the results of this investigation (e.g., immunocompromised, connective&#xD;
                  tissue disease, clinically significant atopic disease, diabetes, and any other&#xD;
                  such disease or illness), that are known to affect postoperative visual acuity.&#xD;
&#xD;
               -  Participation in any investigational drug or device trial within the previous 30&#xD;
                  days prior to the start date of this trial (or currently participating).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Newsom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Newsom Eye &amp; Laser Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Newsom Eye and Laser Center</name>
      <address>
        <city>Sebring</city>
        <state>Florida</state>
        <zip>33870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <results_first_submitted>January 17, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2022</results_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</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>
  <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>February 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04482439/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vivity Monovision Group</title>
          <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unrelated illness</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subject who completed their 3M visit.</population>
      <group_list>
        <group group_id="B1">
          <title>Vivity Monovision Group</title>
          <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="5.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Binocular Near Visual Acuity</title>
        <description>binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Near Visual Acuity</title>
          <description>binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prediction Accuracy</title>
        <description>Percentage of eyes with postoperative refractive accuracy within 0.5D of target</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Prediction Accuracy</title>
          <description>Percentage of eyes with postoperative refractive accuracy within 0.5D of target</description>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spectacle Independence</title>
        <description>Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - &quot;a little of the time&quot; or &quot;none of the time&quot;)</description>
        <time_frame>3 months postop</time_frame>
        <population>All subjects who completed 3M PRSIQ questionnaire successfully</population>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Spectacle Independence</title>
          <description>Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - &quot;a little of the time&quot; or &quot;none of the time&quot;)</description>
          <population>All subjects who completed 3M PRSIQ questionnaire successfully</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Spectacle Independence</title>
        <description>Patients reporting rarely or never needing glasses overall</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Spectacle Independence</title>
          <description>Patients reporting rarely or never needing glasses overall</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Rating Frequency of Visual Disturbances as &quot;Never&quot; or &quot;Rarely&quot;</title>
        <description>This is the frequency of subjects responding, &quot;Never&quot; or &quot;Rarely&quot; to a question about the frequency of glare, halos and starbursts.</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Rating Frequency of Visual Disturbances as &quot;Never&quot; or &quot;Rarely&quot;</title>
          <description>This is the frequency of subjects responding, &quot;Never&quot; or &quot;Rarely&quot; to a question about the frequency of glare, halos and starbursts.</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glare frequency &quot;never&quot; or 'rarely&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Halos frequency &quot;never&quot; or &quot;rarely&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Starbursts frequency &quot;never&quot; or &quot;rarely&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Manifest Refraction</title>
        <description>Manifest refraction (residual spherical equivalent refraction)</description>
        <time_frame>3 months postop</time_frame>
        <population>Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Manifest Refraction</title>
          <description>Manifest refraction (residual spherical equivalent refraction)</description>
          <population>Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects.</population>
          <units>diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eyes targeted for plano</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".01" spread=".31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyes targeted for myopia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.74" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Residual Cylinder</title>
        <description>Residual refractive cylinder after surgery</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Mini-monovision</title>
            <description>Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.&#xD;
Vivity Extended Depth of Focus intraocular lens (IOL): Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Cylinder</title>
          <description>Residual refractive cylinder after surgery</description>
          <units>diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Distance Visual Acuity</title>
        <description>Bilateral uncorrected distance visual acuity</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Distance Visual Acuity</title>
          <description>Bilateral uncorrected distance visual acuity</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Intermediate Visual Acuity</title>
        <description>Bilateral uncorrected visual acuity at 66 cm</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Intermediate Visual Acuity</title>
          <description>Bilateral uncorrected visual acuity at 66 cm</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread=".07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Near Visual Acuity</title>
        <description>Bilateral uncorrected near visual acuity at 40 cm</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Near Visual Acuity</title>
          <description>Bilateral uncorrected near visual acuity at 40 cm</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corrected Distance Visual Acuity</title>
        <description>Bliateral corrected distance visual acuity</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected Distance Visual Acuity</title>
          <description>Bliateral corrected distance visual acuity</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distance Corrected Intermediate Visual Acuity</title>
        <description>Bliateral distance corrected visual acuity at 66 cm</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vivity Monovision Group</title>
            <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Corrected Intermediate Visual Acuity</title>
          <description>Bliateral distance corrected visual acuity at 66 cm</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Surgery to 3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vivity Monovision Group</title>
          <description>Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.</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="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </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>T. Hunter Newsom, MD</name_or_title>
      <organization>Newsom Eye and Laser Center</organization>
      <phone>813-908-2020</phone>
      <email>hunter@newsomeye.net</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/NCT04482439
org study id: TN-20-001
nct id: NCT04482439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of
      patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity
      Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected
      near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after
      successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively
      and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include
      administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle
      independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as
      measurement of bilateral visual acuity and manifest refraction.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
primary purpose: Treatment
masking: None (Open Label)
measure: Binocular Near Visual Acuity
time frame: 3 months postop
description: binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
measure: Prediction Accuracy
time frame: 3 months postop
description: Percentage of eyes with postoperative refractive accuracy within 0.5D of target
measure: Spectacle Independence
time frame: 3 months postop
description: Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
measure: Patient Spectacle Independence
time frame: 3 months postop
description: Patients reporting rarely or never needing glasses overall
measure: Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
time frame: 3 months postop
description: This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
measure: Manifest Refraction
time frame: 3 months postop
description: Manifest refraction (residual spherical equivalent refraction)
measure: Residual Cylinder
time frame: 3 months
description: Residual refractive cylinder after surgery
measure: Uncorrected Distance Visual Acuity
time frame: 3 months postop
description: Bilateral uncorrected distance visual acuity
measure: Uncorrected Intermediate Visual Acuity
time frame: 3 months postop
description: Bilateral uncorrected visual acuity at 66 cm
measure: Uncorrected Near Visual Acuity
time frame: 3 months postop
description: Bilateral uncorrected near visual acuity at 40 cm
measure: Corrected Distance Visual Acuity
time frame: 3 months postop
description: Bliateral corrected distance visual acuity
measure: Distance Corrected Intermediate Visual Acuity
time frame: 3 months postop
description: Bliateral distance corrected visual acuity at 66 cm
arm group label: Vivity mini-monovision
arm group type: Experimental
description: Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.
intervention type: Device
intervention name: Vivity Extended Depth of Focus intraocular lens (IOL)
description: Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
arm group label: Vivity mini-monovision
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Newsom, MD
role: Principal Investigator
affiliation: Newsom Eye & Laser Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 