<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/NCT01714635</url>
  </required_header>
  <id_info>
    <org_study_id>DIOL-106-ZMLA</org_study_id>
    <nct_id>NCT01714635</nct_id>
  </id_info>
  <brief_title>Clinical Investigation of Expanded Designs of a Multifocal IOL</brief_title>
  <official_title>Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS&#xD;
      Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide&#xD;
      statistically better distance-corrected near visual acuity compared to the monofocal control&#xD;
      lens. Complication and adverse event rates associated with each Multifocal IOL will be within&#xD;
      the ISO SPE rate for posterior chamber IOLs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm</measure>
    <time_frame>six months</time_frame>
    <description>Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Diopter Range With VA of 20/40 or Better</measure>
    <time_frame>six months</time_frame>
    <description>Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.&#xD;
* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spectacle Independence</measure>
    <time_frame>six months</time_frame>
    <description>Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">445</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Tecnis Multifocal Intraocular lens #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low diopter add multifocal intraocular lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tecnis Multifocal Intraocular Lens #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low diopter add multifocal intraocular lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monofocal Intraocular Lens</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercially available monofocal intraocular lens (IOL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tecnis Multifocal Intraocular Lens</intervention_name>
    <arm_group_label>Tecnis Multifocal Intraocular Lens #2</arm_group_label>
    <arm_group_label>Tecnis Multifocal Intraocular lens #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monofocal Intraocular Lens</intervention_name>
    <arm_group_label>Monofocal Intraocular Lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum 18 years of age&#xD;
&#xD;
          -  Bilateral cataracts for which phacoemulsification extraction and posterior IOL&#xD;
             implantation have been planned for both eyes&#xD;
&#xD;
          -  Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen)&#xD;
             with or without a glare source&#xD;
&#xD;
          -  Potential for postoperative best-corrected visual acuity of 20/25 or better&#xD;
&#xD;
          -  Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and&#xD;
             no irregular corneal astigmatism&#xD;
&#xD;
          -  Clear intraocular media, other than cataract&#xD;
&#xD;
          -  Availability, willingness and sufficient cognitive awareness to comply with&#xD;
             examination procedures&#xD;
&#xD;
          -  Signed informed consent and HIPAA authorization or equivalent documentation necessary&#xD;
             to comply with applicable privacy laws pertaining to medical treatment in the&#xD;
             governing countries&#xD;
&#xD;
          -  Ability to understand and respond to a questionnaire verbally administered in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D&#xD;
&#xD;
          -  Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)&#xD;
&#xD;
          -  Recent ocular trauma or ocular surgery that is not resolved/stable or may affect&#xD;
             visual outcomes&#xD;
&#xD;
          -  Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery&#xD;
&#xD;
          -  Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are&#xD;
             predicted to cause visual acuity losses to a level of 20/30 or worse during the study&#xD;
&#xD;
          -  Inability to achieve keratometric stability for contact lens wearers&#xD;
&#xD;
          -  Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or&#xD;
             other retinal disorders) that are predicted to cause visual acuity losses to a level&#xD;
             of 20/30 or worse during the study&#xD;
&#xD;
          -  Subjects with conditions associated with increased risk of zonular rupture, including&#xD;
             capsular or zonular abnormalities that may lead to IOL decentration, including&#xD;
             pseudoexfoliation, trauma, or posterior capsule defects&#xD;
&#xD;
          -  Use of systemic or ocular medications that may affect vision&#xD;
&#xD;
          -  Prior, current, or anticipated use during the course of the 12-month study of&#xD;
             tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion&#xD;
             of the investigator, to cause poor dilation or lack of adequate iris structure to&#xD;
             perform standard cataract surgery&#xD;
&#xD;
          -  Inability to focus, fixate or maintain binocular vision for prolonged periods of time&#xD;
             (e.g., due to strabismus, nystagmus, etc.)&#xD;
&#xD;
          -  Poorly-controlled diabetes&#xD;
&#xD;
          -  Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the&#xD;
             opinion of the investigator, would increase the operative risk or confound the&#xD;
             outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected&#xD;
             glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation,&#xD;
             etc.). Note: ocular hypertension without glaucomatous changes is acceptable.&#xD;
&#xD;
          -  Known ocular disease or pathology that may affect visual acuity or that may be&#xD;
             expected to require retinal laser treatment or other surgical intervention during the&#xD;
             course of the study (macular degeneration, cystoid macular edema, diabetic&#xD;
             retinopathy, etc.)&#xD;
&#xD;
          -  Patient is pregnant, plans to become pregnant, is lactating or has another condition&#xD;
             associated with the fluctuation of hormones that could lead to refractive changes&#xD;
&#xD;
          -  Concurrent participation or participation within 30 days prior to preoperative visit&#xD;
             in any other clinical trial&#xD;
&#xD;
          -  Desire for monovision correction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kendra Hileman, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Optics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fishkind, Bakewell &amp; Maltzman Eye Care &amp; Surgery Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boozman-Hof Regional Eye Clinic</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Eye &amp; Laser Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assil Eye Institute</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Coral Eye Center (Argus Research Center)</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virdi Eye Clinic &amp; Laser Vision Center</name>
      <address>
        <city>Rock Island</city>
        <state>Illinois</state>
        <zip>61201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Surgeons of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wallace Eye Surgery</name>
      <address>
        <city>Alexandria</city>
        <state>Louisiana</state>
        <zip>71303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepose Vision Institute</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Long Island</name>
      <address>
        <city>Rockville Center</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Center of Central PA</name>
      <address>
        <city>Allenwood</city>
        <state>Pennsylvania</state>
        <zip>17810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; Christie and Associates, PC</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucci Cataract &amp; Laser Vision</name>
      <address>
        <city>Wilkes Barre</city>
        <state>Pennsylvania</state>
        <zip>18702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loden Vision Center</name>
      <address>
        <city>Goodlettsville</city>
        <state>Tennessee</state>
        <zip>37072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitsett Vision Group</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lone Star Eye Care</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarus Eye Centre</name>
      <address>
        <city>Lacey</city>
        <state>Washington</state>
        <zip>98503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Midline Eye Institute</name>
      <address>
        <city>Solihull</city>
        <zip>B91 2AW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>January 9, 2015</results_first_submitted>
  <results_first_submitted_qc>January 9, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 15, 2015</results_first_posted>
  <last_update_submitted>February 26, 2015</last_update_submitted>
  <last_update_submitted_qc>February 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract</keyword>
  <keyword>IOL</keyword>
  <keyword>intraocular lens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tecnis Multifocal Intraocular Lens #1</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="P2">
          <title>Tecnis Multifocal Intraocular Lens #2</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="P3">
          <title>Monofocal Intraocular Lens</title>
          <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="146"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Discontinued</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed 6-month exam</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tecnis Multifocal Intraocular Lens #1</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="B2">
          <title>Tecnis Multifocal Intraocular Lens #2</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="B3">
          <title>Monofocal Intraocular Lens</title>
          <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
        </group>
        <group group_id="B4">
          <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="147"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="148"/>
            <count group_id="B4" value="445"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Age was grouped by catagories as described in the table.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than 60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 - 69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70 - 79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greater than or equal to 80 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="74"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="260"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="147"/>
                    <measurement group_id="B4" value="443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm</title>
        <description>Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative</description>
        <time_frame>six months</time_frame>
        <population>eyes</population>
        <group_list>
          <group group_id="O1">
            <title>Tecnis Multifocal Intraocular Lens #1</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O2">
            <title>Tecnis Multifocal Intraocular Lens #2</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O3">
            <title>Monofocal Intraocular Lens</title>
            <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm</title>
          <description>Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative</description>
          <population>eyes</population>
          <units>LogMAR VA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.253" spread="0.012"/>
                    <measurement group_id="O2" value="0.179" spread="0.011"/>
                    <measurement group_id="O3" value="0.582" spread="0.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Diopter Range With VA of 20/40 or Better</title>
        <description>Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.&#xD;
* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.</description>
        <time_frame>six months</time_frame>
        <population>eyes</population>
        <group_list>
          <group group_id="O1">
            <title>Tecnis Multifocal Intraocular Lens #1</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O2">
            <title>Tecnis Multifocal Intraocular Lens #2</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O3">
            <title>Monofocal Intraocular Lens</title>
            <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Diopter Range With VA of 20/40 or Better</title>
          <description>Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.&#xD;
* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.</description>
          <population>eyes</population>
          <units>diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.16" spread="0.50"/>
                    <measurement group_id="O2" value="3.30" spread="0.69"/>
                    <measurement group_id="O3" value="1.75" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spectacle Independence</title>
        <description>Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.</description>
        <time_frame>six months</time_frame>
        <population>Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.</population>
        <group_list>
          <group group_id="O1">
            <title>Tecnis Multifocal Intraocular Lens #1</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O2">
            <title>Tecnis Multifocal Intraocular Lens #2</title>
            <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
          </group>
          <group group_id="O3">
            <title>Monofocal Intraocular Lens</title>
            <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Spectacle Independence</title>
          <description>Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.</description>
          <population>Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="111"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tecnis Multifocal Intraocular Lens #1</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="E2">
          <title>Tecnis Multifocal Intraocular Lens #2</title>
          <description>A low diopter add multifocal intraocular lens&#xD;
Tecnis Multifocal Intraocular Lens</description>
        </group>
        <group group_id="E3">
          <title>Monofocal Intraocular Lens</title>
          <description>Commercially available monofocal intraocular lens (IOL)&#xD;
Monofocal Intraocular Lens</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Secondary surgical intervention - not lens-related</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Secondary surgical intervention - lens-related</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Orbital fracture</sub_title>
                <description>Orbital fracture was attributed to a fall. Subject also sustained limbal wound rupture and iris prolapse.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Central retinal artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Endophthalmitis/hypopyon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Cystoid macular edema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</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="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="148"/>
              </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>After the trial is completed, investigators must obtain approval from AMO in writing prior to disclosing trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kendra Hileman, Ph.D., Director, Clinical Research &amp; Development</name_or_title>
      <organization>Abbott Medical Optics</organization>
      <phone>714-247-8613</phone>
      <email>kendra.hileman@amo.abbott.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/NCT01714635
org study id: DIOL-106-ZMLA
nct id: NCT01714635
lead sponsor: 
has dmc: No
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS
      Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide
      statistically better distance-corrected near visual acuity compared to the monofocal control
      lens. Complication and adverse event rates associated with each Multifocal IOL will be within
      the ISO SPE rate for posterior chamber IOLs.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
time frame: six months
description: Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
measure: Mean Diopter Range With VA of 20/40 or Better
time frame: six months
description: Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.
* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.
measure: Spectacle Independence
time frame: six months
description: Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
arm group label: Tecnis Multifocal Intraocular lens #1
arm group type: Experimental
description: A low diopter add multifocal intraocular lens
arm group label: Tecnis Multifocal Intraocular Lens #2
arm group type: Experimental
description: A low diopter add multifocal intraocular lens
arm group label: Monofocal Intraocular Lens
arm group type: Active Comparator
description: Commercially available monofocal intraocular lens (IOL)
intervention type: Device
intervention name: Tecnis Multifocal Intraocular Lens
arm group label: Tecnis Multifocal Intraocular Lens #2
arm group label: Tecnis Multifocal Intraocular lens #1
intervention type: Device
intervention name: Monofocal Intraocular Lens
arm group label: Monofocal Intraocular Lens
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kendra Hileman, PhD
role: Study Director
affiliation: Abbott Medical Optics
facility: 
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country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cataract
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 