<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/NCT01684007</url>
  </required_header>
  <id_info>
    <org_study_id>M-12-007</org_study_id>
    <nct_id>NCT01684007</nct_id>
  </id_info>
  <brief_title>A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients</brief_title>
  <official_title>Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both&#xD;
      eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant&#xD;
      eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral&#xD;
      implantation) at Month 3 following the second eye surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will complete a preoperative examination of both eyes, implantation of IOL at&#xD;
      the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day&#xD;
      1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second&#xD;
      implantation will occur between 1 and 45 days of the first. If the first eye is not implanted&#xD;
      during surgery, the second eye is not eligible. lf both eyes are not implanted with the&#xD;
      assigned IOL, the subject will be followed for safety evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)</measure>
    <time_frame>Day 90 from second eye implantation</time_frame>
    <description>Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)</measure>
    <time_frame>Day 90 from second eye implantation</time_frame>
    <description>VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Cataracts</condition>
  <arm_group>
    <arm_group_label>Bilateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contralateral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]</intervention_name>
    <description>Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient</description>
    <arm_group_label>Bilateral</arm_group_label>
    <arm_group_label>Contralateral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1</intervention_name>
    <description>Multifocal IOL implanted for long-term use over the lifetime of the cataract patient</description>
    <arm_group_label>Contralateral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to understand and sign informed consent, and attend postoperative&#xD;
             examinations per protocol schedule;&#xD;
&#xD;
          -  Requires cataract extraction followed by posterior intraocular lens implantation used&#xD;
             as an on-label procedure in both eyes;&#xD;
&#xD;
          -  Willing to have second eye surgery within 45 days of first eye surgery;&#xD;
&#xD;
          -  Expected postoperative astigmatism &lt; 1.0 D in both eyes, as measured by keratometry;&#xD;
&#xD;
          -  Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section&#xD;
             of the package inserts;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This&#xD;
             exclusion did not apply to binocular (OU) measurement;&#xD;
&#xD;
          -  Significant irregular corneal astigmatism as demonstrated by corneal topography;&#xD;
&#xD;
          -  Severe degenerative visual disorders;&#xD;
&#xD;
          -  Previous corneal surgery;&#xD;
&#xD;
          -  Amblyopia;&#xD;
&#xD;
          -  Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course&#xD;
             of the study;&#xD;
&#xD;
          -  History of corneal disease;&#xD;
&#xD;
          -  Severe diabetic retinopathy;&#xD;
&#xD;
          -  History of retinal detachment;&#xD;
&#xD;
          -  Severe conditions or acute or chronic diseases or illnesses that, per investigator's&#xD;
             clinical judgment, would increase the operative risk or confound the results of the&#xD;
             study;&#xD;
&#xD;
          -  Pregnant or planning pregnancy during course of study;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magda Michna, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>May 8, 2015</results_first_submitted>
  <results_first_submitted_qc>May 8, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 27, 2015</results_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular lens</keyword>
  <keyword>Multifocal intraocular lens (MIOL)</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>
      <recruitment_details>Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).</recruitment_details>
      <pre_assignment_details>Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bilateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation</description>
        </group>
        <group group_id="P2">
          <title>Contralateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral 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="53"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all implanted subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Bilateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation</description>
        </group>
        <group group_id="B2">
          <title>Contralateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral 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="53"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="103"/>
          </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="67.2" spread="7.9"/>
                    <measurement group_id="B2" value="65.9" spread="10.1"/>
                    <measurement group_id="B3" value="66.6" spread="9.0"/>
                  </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="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </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>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)</title>
        <description>Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
        <time_frame>Day 90 from second eye implantation</time_frame>
        <population>This analysis population includes all subjects with both eyes implanted.</population>
        <group_list>
          <group group_id="O1">
            <title>Bilateral</title>
            <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>Contralateral</title>
            <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)</title>
          <description>Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
          <population>This analysis population includes all subjects with both eyes implanted.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.148"/>
                    <measurement group_id="O2" value="0.09" spread="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)</title>
        <description>VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
        <time_frame>Day 90 from second eye implantation</time_frame>
        <population>This analysis population includes all subjects with both eyes implanted.</population>
        <group_list>
          <group group_id="O1">
            <title>Bilateral</title>
            <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation</description>
          </group>
          <group group_id="O2">
            <title>Contralateral</title>
            <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)</title>
          <description>VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.</description>
          <population>This analysis population includes all subjects with both eyes implanted.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.158"/>
                    <measurement group_id="O2" value="0.10" spread="0.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).</time_frame>
      <desc>An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bilateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation</description>
        </group>
        <group group_id="E2">
          <title>Contralateral</title>
          <description>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <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="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </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>Magda Michna, Expert Clinical Lead, Surgical</name_or_title>
      <organization>Alcon Research, Ltd.</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/NCT01684007
org study id: M-12-007
nct id: NCT01684007
lead sponsor: 
has dmc: No
The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both
      eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant
      eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral
      implantation) at Month 3 following the second eye surgery.
Each subject will complete a preoperative examination of both eyes, implantation of IOL at
      the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day
      1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second
      implantation will occur between 1 and 45 days of the first. If the first eye is not implanted
      during surgery, the second eye is not eligible. lf both eyes are not implanted with the
      assigned IOL, the subject will be followed for safety evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
time frame: Day 90 from second eye implantation
description: Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
measure: Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
time frame: Day 90 from second eye implantation
description: VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
arm group label: Bilateral
arm group type: Experimental
description: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
arm group label: Contralateral
arm group type: Active Comparator
description: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation
intervention type: Device
intervention name: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
description: Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
arm group label: Bilateral
arm group label: Contralateral
intervention type: Device
intervention name: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
description: Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
arm group label: Contralateral
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Magda Michna, PhD
role: Study Director
affiliation: Alcon Research
responsible party type: Sponsor
mesh term: Cataract
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 