<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/NCT03010254</url>
  </required_header>
  <id_info>
    <org_study_id>ILI875-C001</org_study_id>
    <nct_id>NCT03010254</nct_id>
  </id_info>
  <brief_title>A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)</brief_title>
  <official_title>A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF&#xD;
      IOL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar&#xD;
      days and a maximum of 28 calendar days from the first eye implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 17, 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) at 66 Centimeters (cm)</measure>
    <time_frame>Month 3 (70-100 days post second eye implantation)</time_frame>
    <description>Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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>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 by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)</measure>
    <time_frame>Month 3 (70-100 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm</measure>
    <time_frame>Month 3 (70-100 days post second eye implantation)</time_frame>
    <description>VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. 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>Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve</measure>
    <time_frame>Month 3 (70-100 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, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. 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. 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)</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 feet (2.45 m) from the eye at a spatial frequency of 12 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Respond &quot;Never&quot; to Question 1 of the Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Any Purpose?&quot;</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Respond &quot;Never&quot; to Question 3 of the Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?&quot;</measure>
    <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
    <description>No formal statistical hypothesis testing was planned.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">322</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; intended for long-term use over the lifetime of the pseudophakic subject</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;
          -  Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional&#xD;
             Review Board (IRB) approved Informed Consent Form;&#xD;
&#xD;
          -  Diagnosed with cataract in both eyes;&#xD;
&#xD;
          -  Planned cataract removal by routine small incision surgery;&#xD;
&#xD;
          -  Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D)&#xD;
             in 0.5 D steps);&#xD;
&#xD;
          -  Preoperative regular astigmatism of less than 1.0 D.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation current or planned during the course of the study;&#xD;
&#xD;
          -  History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment&#xD;
             (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease,&#xD;
             retinal detachment or peripheral retinal laser photocoagulation, age-related macular&#xD;
             degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular&#xD;
             hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve&#xD;
             pathology.&#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>Senior Clinical Manager, GCRA</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Hawthorn East</city>
        <state>Victoria</state>
        <zip>3123</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 3N9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5L1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3N 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Boisbriand</city>
        <state>QU</state>
        <zip>J7H 186</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Québec</city>
        <state>QU</state>
        <zip>G1S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Sant Cugat del Vallès</city>
        <state>BCN</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Jerez De La Frontera</city>
        <state>Cadiz</state>
        <zip>11408</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08021</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Dartford</city>
        <state>Kent</state>
        <zip>DA2 8DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Essex</city>
        <zip>SS0 9AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>London</city>
        <zip>NW1 5QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 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>August 12, 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>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>May 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03010254/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03010254/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom.</recruitment_details>
      <pre_assignment_details>A total of 322 subjects were enrolled in the study, out of which 39 subjects exited due to screen failure and 1 subject discontinued due to site being closed before actual screening visit and randomization. This reporting group includes all randomized subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DFT015</title>
          <description>ACRYSOF® IQ Extended Depth of Focus Intraocular lens (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="159"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Attempted Implantation</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Successful Implantation</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </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).</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="156"/>
            <count group_id="B2" value="120"/>
            <count group_id="B3" value="276"/>
          </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="69.7" spread="7.37"/>
                    <measurement group_id="B2" value="69.7" spread="7.54"/>
                    <measurement group_id="B3" value="69.7" spread="7.43"/>
                  </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="94"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="117"/>
                  </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="31"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="186"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </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="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="230"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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) at 66 Centimeters (cm)</title>
        <description>Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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 3 (70-100 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set</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) at 66 Centimeters (cm)</title>
          <description>Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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</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="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.175" spread="0.0137"/>
                    <measurement group_id="O2" value="0.313" spread="0.0158"/>
                  </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>-0.138</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0210</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.180</ci_lower_limit>
            <ci_upper_limit>-0.097</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </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 by ISO 11979-7:2014 were collected for 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). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.</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 by ISO 11979-7:2014 were collected for 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). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.</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="156"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cumulative: Cystoid macular oedema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <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="0.6"/>
                    <measurement group_id="O2" value="0.6"/>
                  </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>Secondary</type>
        <title>Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)</title>
        <description>VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, 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 3 (70-100 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set</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) at 4 Meters (m)</title>
          <description>VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, 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</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="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.0076"/>
                    <measurement group_id="O2" value="-0.044" spread="0.0087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin was 0.1 logMAR.</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.037</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0115</dispersion_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.059</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm</title>
        <description>VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. 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 3 (70-100 days post second eye implantation)</time_frame>
        <population>All-Implanted Analysis Set</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) at 40 cm</title>
          <description>VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. 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</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="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.420" spread="0.0142"/>
                    <measurement group_id="O2" value="0.510" spread="0.0163"/>
                  </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>-0.090</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0216</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.133</ci_lower_limit>
            <ci_upper_limit>-0.048</ci_upper_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve</title>
        <description>Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. 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. 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 3 (70-100 days post second eye implantation)</time_frame>
        <population>This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). 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 Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve</title>
          <description>Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. 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. 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>This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). 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="151"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61"/>
                    <measurement group_id="O2" value="1.09"/>
                  </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>Mean difference in depth of focus</param_type>
            <param_value>0.52</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Mean difference in depth of focus (DFT015 - SN60WF)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)</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 feet (2.45 m) from the eye at a spatial frequency of 12 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.</description>
        <time_frame>Month 6 (120-180 days post second eye implantation)</time_frame>
        <population>All-Implanted 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>Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)</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 feet (2.45 m) from the eye at a spatial frequency of 12 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.</description>
          <population>All-Implanted 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>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="156"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Without Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.799" spread="0.0364"/>
                    <measurement group_id="O2" value="0.978" spread="0.0413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With Glare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.794" spread="0.0357"/>
                    <measurement group_id="O2" value="0.975" spread="0.0406"/>
                  </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>
            <groups_desc>Without glare</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin was -0.15 log unit</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.179</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0551</dispersion_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-0.287</ci_lower_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>With glare</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin was -0.15 log unit</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.181</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0541</dispersion_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-0.287</ci_lower_limit>
            <estimate_desc>Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Respond &quot;Never&quot; to Question 1 of the Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Any Purpose?&quot;</title>
        <description>Proportion of subjects was reported as a percentage. 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</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 Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Any Purpose?&quot;</title>
          <description>Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in percentage</param_type>
            <param_value>20.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.77</ci_lower_limit>
            <ci_upper_limit>31.04</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>Percentage of Subjects Who Respond &quot;Never&quot; to Question 3 of the Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?&quot;</title>
        <description>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</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 3 of the Spectacle Use Questionnaire: &quot;How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?&quot;</title>
          <description>No formal statistical hypothesis testing was planned.</description>
          <population>All-Implanted Analysis Set</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5"/>
                    <measurement group_id="O2" value="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent difference</param_type>
            <param_value>21.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.92</ci_lower_limit>
            <ci_upper_limit>35.06</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_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 (19.0)</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="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </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="276"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Posterior capsule rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Refraction disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Vitreous loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </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="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </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="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Intraocular lens repositioning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Keratomileusis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Vitrectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="120"/>
              </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/NCT03010254
org study id: ILI875-C001
nct id: NCT03010254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF
      IOL.
Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar
      days and a maximum of 28 calendar days from the first eye implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
time frame: Month 3 (70-100 days post second eye implantation)
description: Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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 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 by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
measure: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
time frame: Month 3 (70-100 days post second eye implantation)
description: VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, 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 Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
time frame: Month 3 (70-100 days post second eye implantation)
description: VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. 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 Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
time frame: Month 3 (70-100 days post second eye implantation)
description: Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. 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. 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: Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
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 feet (2.45 m) from the eye at a spatial frequency of 12 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.
measure: Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
time frame: Month 6 (120-180 days post second eye implantation)
description: Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
measure: Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"
time frame: Month 6 (120-180 days post second eye implantation)
description: 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; intended for long-term use over the lifetime of the pseudophakic subject
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: Senior Clinical Manager, GCRA
role: Study Director
affiliation: Alcon Research
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country: Australia
country: Canada
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 