<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/NCT03274986</url>
  </required_header>
  <id_info>
    <org_study_id>ILI875-C002</org_study_id>
    <nct_id>NCT03274986</nct_id>
  </id_info>
  <brief_title>A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)</brief_title>
  <official_title>A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended&#xD;
      depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of&#xD;
      focal plane displacement behind a lens that does not degrade the image quality of a distant&#xD;
      object. A larger DOF allows sharp images of closer objects and may provide improved vision at&#xD;
      intermediate and near distances.&#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 9 scheduled study visits&#xD;
      over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the&#xD;
      remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6&#xD;
      (Day 120-180) post second eye implantation visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">October 16, 2018</completion_date>
  <primary_completion_date type="Actual">October 16, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Ocular Adverse Events</measure>
    <time_frame>Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mesopic Contrast Sensitivity</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: &quot;Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?&quot;</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>DFT015</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SN60WF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACRYSOF® IQ Extended Depth of Focus IOL</intervention_name>
    <description>Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.</description>
    <arm_group_label>DFT015</arm_group_label>
    <other_name>Model DFT015</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACRYSOF® IQ Monofocal IOL</intervention_name>
    <description>Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject</description>
    <arm_group_label>SN60WF</arm_group_label>
    <other_name>Model SN60WF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>IOL bilateral implantation</description>
    <arm_group_label>DFT015</arm_group_label>
    <arm_group_label>SN60WF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of&#xD;
             resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source&#xD;
             present (e.g., Brightness Acuity Tester)&#xD;
&#xD;
          -  Preoperative regular astigmatism of &lt; 1.0 D in both eyes&#xD;
&#xD;
          -  Clear intraocular media other than cataract&#xD;
&#xD;
          -  Diagnosed with cataract in both eyes&#xD;
&#xD;
          -  Planned cataract removal by routine small incision surgery&#xD;
&#xD;
          -  Calculated lens power between 18.0 and 25.0 diopter (D) [when targeted for emmetropia&#xD;
             (0.0 D)]&#xD;
&#xD;
          -  Willing and able to complete all required postoperative visits&#xD;
&#xD;
          -  Able to comprehend and sign an ethics committee-approved statement of informed consent&#xD;
&#xD;
          -  Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye&#xD;
             based on Investigator's medical opinion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of eye pathology and/or inflammation, as specified in the protocol&#xD;
&#xD;
          -  Clinically significant/severe ocular surface disease that would affect study&#xD;
             measurements based on Investigator expert medical opinion&#xD;
&#xD;
          -  History of previous intraocular or corneal surgery&#xD;
&#xD;
          -  Pregnant/lactating or has another condition with associated fluctuation of hormones&#xD;
             that could lead to refractive changes&#xD;
&#xD;
          -  Taking systemic medications that in the Investigator's best medical judgment may&#xD;
             confound the outcome or increase the risk to the subject.&#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>Birmingham</city>
        <state>Alabama</state>
        <zip>35213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Sebring</city>
        <state>Florida</state>
        <zip>33870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Rock Island</city>
        <state>Illinois</state>
        <zip>61201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Allenwood</city>
        <state>Pennsylvania</state>
        <zip>17810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>West Mifflin</city>
        <state>Pennsylvania</state>
        <zip>15122</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>March 10, 2020</results_first_submitted>
  <results_first_submitted_qc>March 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2020</results_first_posted>
  <disposition_first_submitted>October 2, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>March 25, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 7, 2020</disposition_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03274986/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03274986/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 11 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DFT015</title>
          <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
        </group>
        <group group_id="P2">
          <title>SN60WF</title>
          <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Successful Implantation, as Treated</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population included all randomized eyes with successful IOL implantation (All-Implanted Analysis Set), as treated.</population>
      <group_list>
        <group group_id="B1">
          <title>DFT015</title>
          <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
        </group>
        <group group_id="B2">
          <title>SN60WF</title>
          <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</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="107"/>
            <count group_id="B2" value="113"/>
            <count group_id="B3" value="220"/>
          </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="68.8" spread="7.82"/>
                    <measurement group_id="B2" value="68.8" spread="6.63"/>
                    <measurement group_id="B3" value="68.8" spread="7.22"/>
                  </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="59"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane</title>
        <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane</title>
          <description>Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set, as treated</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="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.148" spread="0.0120"/>
                    <measurement group_id="O2" value="0.312" spread="0.0118"/>
                  </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>
            <p_value_desc>2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.164</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0168</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.197</ci_lower_limit>
            <ci_upper_limit>-0.131</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane</title>
        <description>VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane</title>
          <description>VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set, as treated</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="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.016" spread="0.0091"/>
                    <measurement group_id="O2" value="-0.036" spread="0.0089"/>
                  </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 margin was 0.1 logMAR.</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.052</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0127</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.073</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve</title>
        <description>Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve</title>
          <description>Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.</population>
          <units>diopter</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53"/>
                    <measurement group_id="O2" value="0.99"/>
                  </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>Other</non_inferiority_type>
            <param_type>Difference in depth of focus</param_type>
            <param_value>0.54</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Difference in depth of focus (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better</title>
        <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better</title>
          <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set, as treated.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.9"/>
                    <measurement group_id="O2" value="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Ocular Adverse Events</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015 First Eye</title>
            <description>All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye</description>
          </group>
          <group group_id="O2">
            <title>DFT015 Second Eye</title>
            <description>All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Ocular Adverse Events</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.</description>
          <population>This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cumulative: Cystoid macular oedema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Hypopyon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Endophthalmitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Lens dislocated from posterior chamber</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Pupillary block</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Retinal detachment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Secondary surgical intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Cataract operation complication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Hyphaema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumulative: Transient ischaemic attack</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent: Corneal stroma oedema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent: Cystoid macular oedema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent: Iritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent: Raised IOP requiring treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mesopic Contrast Sensitivity</title>
        <description>Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Mesopic Contrast Sensitivity</title>
          <description>Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
          <population>Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.</population>
          <units>log unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.5 cpd Without Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.506" spread="0.2560"/>
                    <measurement group_id="O2" value="1.498" spread="0.2434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 cpd Without Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.447" spread="0.3381"/>
                    <measurement group_id="O2" value="1.482" spread="0.2829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd Without Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.340" spread="0.3850"/>
                    <measurement group_id="O2" value="1.548" spread="0.3177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd Without Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.840" spread="0.3681"/>
                    <measurement group_id="O2" value="1.003" spread="0.3769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 cpd With Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.504" spread="0.2555"/>
                    <measurement group_id="O2" value="1.475" spread="0.2569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 cpd With Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.458" spread="0.3304"/>
                    <measurement group_id="O2" value="1.499" spread="0.2838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 cpd With Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.364" spread="0.3856"/>
                    <measurement group_id="O2" value="1.529" spread="0.3256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 cpd With Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.817" spread="0.3494"/>
                    <measurement group_id="O2" value="0.999" spread="0.4020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane</title>
        <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane</title>
          <description>VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.</description>
          <population>All-Implanted Analysis Set, as treated.</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="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.359" spread="0.0147"/>
                    <measurement group_id="O2" value="0.515" spread="0.0144"/>
                  </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>
            <p_value_desc>2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.156</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0206</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.197</ci_lower_limit>
            <ci_upper_limit>-0.115</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: &quot;Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?&quot;</title>
        <description>The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Respond &quot;Never&quot; to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: &quot;Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?&quot;</title>
          <description>The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.</description>
          <population>All-Implanted Analysis Set, as treated.</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="102"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6"/>
                    <measurement group_id="O2" value="3.6"/>
                  </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>Other</non_inferiority_type>
            <param_type>Difference in percentage</param_type>
            <param_value>18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.65</ci_lower_limit>
            <ci_upper_limit>27.37</ci_upper_limit>
            <estimate_desc>95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane</title>
        <description>VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane</title>
          <description>VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set, as treated.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.136" spread="0.110"/>
                    <measurement group_id="O2" value="0.261" spread="0.147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)</title>
        <description>VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set, as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)</title>
          <description>VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set, as treated.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.117" spread="0.122"/>
                    <measurement group_id="O2" value="0.056" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)</title>
        <description>Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.</population>
        <group_list>
          <group group_id="O1">
            <title>DFT015</title>
            <description>ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>SN60WF</title>
            <description>ACRYSOF® IQ Monofocal IOL, bilateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)</title>
          <description>Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.</description>
          <population>Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.</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="106"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Severe: Starbursts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Halos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Hazy vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Blurred vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Double vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Dark area</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Starbursts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Halos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Hazy vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Blurred vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Double vision</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most Bothersome: Dark area</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months</time_frame>
      <desc>An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. &quot;At Risk&quot; population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.</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>DFT015 First Eye</title>
          <description>All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye</description>
        </group>
        <group group_id="E3">
          <title>DFT015 Second Eye</title>
          <description>All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye</description>
        </group>
        <group group_id="E4">
          <title>DFT015 Systemic</title>
          <description>All subjects with attempted test article implantation (successful or aborted after contact with the eye)</description>
        </group>
        <group group_id="E5">
          <title>SN60WF First Eye</title>
          <description>All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye</description>
        </group>
        <group group_id="E6">
          <title>SN60WF Second Eye</title>
          <description>All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye</description>
        </group>
        <group group_id="E7">
          <title>SN60WF Systemic</title>
          <description>All subjects with attempted control article implantation (successful or aborted after contact with the eye)</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="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Heart valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Hyphaema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bladder injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Cataract operation complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Post procedural bile leak</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Surgical procedure repeated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Aneurysm repair</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Lens extraction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </event>
              <event>
                <sub_title>Vitrectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </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="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </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="220"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="107"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="113"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="113"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="113"/>
              </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>CDMA Project Lead</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/NCT03274986
org study id: ILI875-C002
nct id: NCT03274986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended
      depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of
      focal plane displacement behind a lens that does not degrade the image quality of a distant
      object. A larger DOF allows sharp images of closer objects and may provide improved vision at
      intermediate and near distances.
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 9 scheduled study visits
      over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the
      remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6
      (Day 120-180) post second eye implantation visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
time frame: Month 6 (120-180 days post second eye implantation)
description: Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
measure: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
time frame: Month 6 (120-180 days post second eye implantation)
description: VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
measure: Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
time frame: Month 6 (120-180 days post second eye implantation)
description: Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
measure: Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
time frame: Month 6 (120-180 days post second eye implantation)
description: VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
measure: Percentage of Subjects With Ocular Adverse Events
time frame: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
description: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
measure: Mesopic Contrast Sensitivity
time frame: Month 6 (120-180 days post second eye implantation)
description: Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
measure: Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
time frame: Month 6 (120-180 days post second eye implantation)
description: VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
measure: Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"
time frame: Month 6 (120-180 days post second eye implantation)
description: The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.
measure: Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
time frame: Month 6 (120-180 days post second eye implantation)
description: VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
measure: Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
time frame: Month 6 (120-180 days post second eye implantation)
description: VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
measure: Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
time frame: Month 6 (120-180 days post second eye implantation)
description: Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.
arm group label: DFT015
arm group type: Experimental
description: ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
arm group label: SN60WF
arm group type: Active Comparator
description: ACRYSOF® IQ Monofocal IOL, bilateral implantation
intervention type: Device
intervention name: ACRYSOF® IQ Extended Depth of Focus IOL
description: Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.
arm group label: DFT015
other name: Model DFT015
intervention type: Device
intervention name: ACRYSOF® IQ Monofocal IOL
description: Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
arm group label: SN60WF
other name: Model SN60WF
intervention type: Procedure
intervention name: Cataract surgery
description: IOL bilateral implantation
arm group label: DFT015
arm group label: SN60WF
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Alcon Research
role: Study Director
affiliation: Alcon Research
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country: United States
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 