<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/NCT03280108</url>
  </required_header>
  <id_info>
    <org_study_id>ILH297-C001</org_study_id>
    <nct_id>NCT03280108</nct_id>
  </id_info>
  <brief_title>Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00</brief_title>
  <official_title>Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ&#xD;
      PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the&#xD;
      AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and&#xD;
      superior near and intermediate vision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both eyes of a subject must require cataract surgery to qualify for enrollment into this&#xD;
      study. Subjects participating in the trial will attend a total of 10 study visits over a&#xD;
      7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7&#xD;
      are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day&#xD;
      120-180) post second eye implantation visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">September 27, 2018</completion_date>
  <primary_completion_date type="Actual">September 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye</measure>
    <time_frame>Up to Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Photopic Without Glare Binocular Distance Contrast Sensitivity</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Photopic With Glare Binocular Distance Contrast Sensitivity</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Mesopic With Glare Binocular Distance Contrast Sensitivity</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, &quot;Overall, in the past 7 days, how often did you need to wear eyeglasses to see?&quot; The proportion of subjects who respond &quot;Never&quot; is reported as a percentage calculated as (# of subjects responding &quot;Never&quot;) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding &quot;Severe&quot; was calculated as (# of subjects responding &quot;Severe&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID</measure>
    <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
    <description>Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding &quot;Bothered very much&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Multifocal IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monofocal IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcrySof IQ PanOptix Multifocal IOL</intervention_name>
    <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision</description>
    <arm_group_label>Multifocal IOL</arm_group_label>
    <other_name>Model TFNT00</other_name>
    <other_name>AcrySof® IQ PanOptix®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcrySof Monofocal IOL</intervention_name>
    <description>AcrySof Monofocal IOL Model SN60AT for single vision</description>
    <arm_group_label>Monofocal IOL</arm_group_label>
    <other_name>Model SN60AT</other_name>
    <other_name>AcrySof®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with bilateral cataracts with planned cataract removal by&#xD;
             phacoemulsification with a clear cornea incision&#xD;
&#xD;
          -  Able to comprehend and willing to sign informed consent and complete all required&#xD;
             postoperative follow-up procedures&#xD;
&#xD;
          -  Clear intraocular media other than cataract in both eyes.&#xD;
&#xD;
          -  Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative&#xD;
             eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant corneal abnormalities including corneal dystrophy,&#xD;
             irregularity, inflammation or edema&#xD;
&#xD;
          -  Previous refractive surgery or refractive surgery procedures (including, but not&#xD;
             limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)&#xD;
&#xD;
          -  Glaucoma (uncontrolled or controlled with medication)&#xD;
&#xD;
          -  Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Expected to require a second surgical intervention or retinal laser treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alcon Research</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Mount Dora</city>
        <state>Florida</state>
        <zip>32757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Nacogdoches</city>
        <state>Texas</state>
        <zip>75965</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>September 19, 2019</results_first_submitted>
  <results_first_submitted_qc>October 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2019</results_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular lens</keyword>
  <keyword>IOL</keyword>
  <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</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03280108/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03280108/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 12 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TFNT00</title>
          <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
        </group>
        <group group_id="P2">
          <title>SN60AT</title>
          <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </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="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all eyes with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).</population>
      <group_list>
        <group group_id="B1">
          <title>TFNT00</title>
          <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
        </group>
        <group group_id="B2">
          <title>SN60AT</title>
          <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</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="129"/>
            <count group_id="B2" value="114"/>
            <count group_id="B3" value="243"/>
          </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="65.8" spread="7.31"/>
                    <measurement group_id="B2" value="69.0" spread="6.46"/>
                    <measurement group_id="B3" value="67.3" spread="7.09"/>
                  </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="85"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)</title>
        <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>All-Implanted Analysis Set with data available at the visit</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)</title>
          <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set with data available at the visit</population>
          <units>logMAR</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.014" spread="0.0083"/>
                    <measurement group_id="O2" value="-0.039" spread="0.0087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.024</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0103</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.041</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)</title>
        <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>All-Implanted Analysis Set with data at visit</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)</title>
          <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set with data at visit</population>
          <units>logMAR</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.105" spread="0.0119"/>
                    <measurement group_id="O2" value="0.529" spread="0.0127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye</title>
        <description>The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.</description>
        <time_frame>Up to Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye</title>
          <description>The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.</description>
          <population>This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).</population>
          <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="129"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Photopic Without Glare Binocular Distance Contrast Sensitivity</title>
        <description>Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>Safety Analysis Set with contrast sensitivity test</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Photopic Without Glare Binocular Distance Contrast Sensitivity</title>
          <description>Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
          <population>Safety Analysis Set with contrast sensitivity test</population>
          <units>log units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.752" spread="0.2080"/>
                    <measurement group_id="O2" value="1.733" spread="0.1989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.923" spread="0.2349"/>
                    <measurement group_id="O2" value="1.940" spread="0.2328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.527" spread="0.2793"/>
                    <measurement group_id="O2" value="1.558" spread="0.2566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.993" spread="0.2874"/>
                    <measurement group_id="O2" value="1.090" spread="0.2661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Photopic With Glare Binocular Distance Contrast Sensitivity</title>
        <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>Safety Analysis Set with contrast sensitivity test</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Photopic With Glare Binocular Distance Contrast Sensitivity</title>
          <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
          <population>Safety Analysis Set with contrast sensitivity test</population>
          <units>log units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.759" spread="0.1890"/>
                    <measurement group_id="O2" value="1.753" spread="0.1928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.897" spread="0.2322"/>
                    <measurement group_id="O2" value="1.971" spread="0.1952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.566" spread="0.2728"/>
                    <measurement group_id="O2" value="1.593" spread="0.2659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.037" spread="0.2762"/>
                    <measurement group_id="O2" value="1.121" spread="0.2537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity</title>
        <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>Safety Analysis Set with contrast sensitivity test</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity</title>
          <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
          <population>Safety Analysis Set with contrast sensitivity test</population>
          <units>log units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.5 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.673" spread="0.2601"/>
                    <measurement group_id="O2" value="1.679" spread="0.2190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.717" spread="0.2397"/>
                    <measurement group_id="O2" value="1.689" spread="0.2177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.715" spread="0.2875"/>
                    <measurement group_id="O2" value="1.777" spread="0.2871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.211" spread="0.4047"/>
                    <measurement group_id="O2" value="1.290" spread="0.4384"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Mesopic With Glare Binocular Distance Contrast Sensitivity</title>
        <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>Safety Analysis Set with contrast sensitivity test</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Mesopic With Glare Binocular Distance Contrast Sensitivity</title>
          <description>Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.</description>
          <population>Safety Analysis Set with contrast sensitivity test</population>
          <units>log units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.5 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.658" spread="0.2296"/>
                    <measurement group_id="O2" value="1.678" spread="0.2091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.709" spread="0.2307"/>
                    <measurement group_id="O2" value="1.692" spread="0.2089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.691" spread="0.3238"/>
                    <measurement group_id="O2" value="1.786" spread="0.2775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.129" spread="0.4146"/>
                    <measurement group_id="O2" value="1.233" spread="0.4599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)</title>
        <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>All-Implanted Analysis Set with data at visit</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)</title>
          <description>VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set with data at visit</population>
          <units>logMAR</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.070" spread="0.0108"/>
                    <measurement group_id="O2" value="0.327" spread="0.0114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.257</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0153</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.287</ci_lower_limit>
            <ci_upper_limit>-0.227</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire</title>
        <description>The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, &quot;Overall, in the past 7 days, how often did you need to wear eyeglasses to see?&quot; The proportion of subjects who respond &quot;Never&quot; is reported as a percentage calculated as (# of subjects responding &quot;Never&quot;) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire</title>
          <description>The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, &quot;Overall, in the past 7 days, how often did you need to wear eyeglasses to see?&quot; The proportion of subjects who respond &quot;Never&quot; is reported as a percentage calculated as (# of subjects responding &quot;Never&quot;) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.</description>
          <population>This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.5"/>
                    <measurement group_id="O2" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mantel-Haenszel common difference</param_type>
            <param_value>71.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>61.87</ci_lower_limit>
            <ci_upper_limit>80.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)</title>
        <description>QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding &quot;Severe&quot; was calculated as (# of subjects responding &quot;Severe&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>This analysis population includes all subjects with bilateral implantation and non-missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)</title>
          <description>QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding &quot;Severe&quot; was calculated as (# of subjects responding &quot;Severe&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
          <population>This analysis population includes all subjects with bilateral implantation and non-missing data.</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="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Starbursts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Halos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hazy vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blurred vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Double vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dark area</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID</title>
        <description>Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding &quot;Bothered very much&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
        <time_frame>Month 6 (Day 120-180), post second eye implantation</time_frame>
        <population>This analysis population includes all subjects with bilateral implantation and non-missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>TFNT00</title>
            <description>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
          <group group_id="O2">
            <title>SN60AT</title>
            <description>AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID</title>
          <description>Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding &quot;Bothered very much&quot;) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.</description>
          <population>This analysis population includes all subjects with bilateral implantation and non-missing data.</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="127"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Starbursts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Halos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hazy vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blurred vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Double vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dark area</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Implantation through study completion, an average of 7 months</time_frame>
      <desc>Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). &quot;At Risk&quot; population for ocular AEs is included with unit of &quot;eyes.&quot;</desc>
      <group_list>
        <group group_id="E1">
          <title>Preoperative</title>
          <description>All subjects in the safety analysis set prior to initiation of treatment.</description>
        </group>
        <group group_id="E2">
          <title>TFNT00 - 1st Eye</title>
          <description>All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.</description>
        </group>
        <group group_id="E3">
          <title>TFNT00 - 2nd Eye</title>
          <description>All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.</description>
        </group>
        <group group_id="E4">
          <title>TFNT00 - Systemic</title>
          <description>All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.</description>
        </group>
        <group group_id="E5">
          <title>SN60AT - 1st Eye</title>
          <description>All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT.</description>
        </group>
        <group group_id="E6">
          <title>SN60AT - 2nd Eye</title>
          <description>All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT.</description>
        </group>
        <group group_id="E7">
          <title>SN60AT - Systemic</title>
          <description>All subjects implanted with AcrySof Monofocal IOL Model SN60AT.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Age-related macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Posterior capsule rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Vitreous prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Colectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Intra-ocular injection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Intraocular lens repositioning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Lens extraction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Vitrectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="129"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="127"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="114"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Expert Clinical Project Lead, CDMA Surgical</name_or_title>
      <organization>Alcon Research</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280108
org study id: ILH297-C001
nct id: NCT03280108
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ
      PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the
      AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and
      superior near and intermediate vision.
Both eyes of a subject must require cataract surgery to qualify for enrollment into this
      study. Subjects participating in the trial will attend a total of 10 study visits over a
      7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7
      are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day
      120-180) post second eye implantation visit.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
time frame: Month 6 (Day 120-180), post second eye implantation
description: Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
measure: Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
time frame: Month 6 (Day 120-180), post second eye implantation
description: VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
measure: Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
time frame: Up to Month 6 (Day 120-180), post second eye implantation
description: The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
measure: Mean Photopic Without Glare Binocular Distance Contrast Sensitivity
time frame: Month 6 (Day 120-180), post second eye implantation
description: Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
measure: Mean Photopic With Glare Binocular Distance Contrast Sensitivity
time frame: Month 6 (Day 120-180), post second eye implantation
description: Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
measure: Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity
time frame: Month 6 (Day 120-180), post second eye implantation
description: Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
measure: Mean Mesopic With Glare Binocular Distance Contrast Sensitivity
time frame: Month 6 (Day 120-180), post second eye implantation
description: Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
measure: Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
time frame: Month 6 (Day 120-180), post second eye implantation
description: VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
measure: Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
time frame: Month 6 (Day 120-180), post second eye implantation
description: The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
measure: Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
time frame: Month 6 (Day 120-180), post second eye implantation
description: QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
measure: Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
time frame: Month 6 (Day 120-180), post second eye implantation
description: Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
arm group label: Multifocal IOL
arm group type: Experimental
description: AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
arm group label: Monofocal IOL
arm group type: Active Comparator
description: AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
intervention type: Device
intervention name: AcrySof IQ PanOptix Multifocal IOL
description: AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
arm group label: Multifocal IOL
other name: Model TFNT00
other name: AcrySof® IQ PanOptix®
intervention type: Device
intervention name: AcrySof Monofocal IOL
description: AcrySof Monofocal IOL Model SN60AT for single vision
arm group label: Monofocal IOL
other name: Model SN60AT
other name: AcrySof®
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Alcon Research
role: Study Director
affiliation: Alcon Research
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 