<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/NCT02219997</url>
  </required_header>
  <id_info>
    <org_study_id>ILQ830-P001</org_study_id>
    <nct_id>NCT02219997</nct_id>
  </id_info>
  <brief_title>Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration</brief_title>
  <official_title>Functional Benefit With ACRYSOF® Natural Chromophore</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 the reaction time (as measured by braking reaction&#xD;
      time in seconds during simulated driving) under glare and no-glare conditions in subjects&#xD;
      implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.&#xD;
      This study will enroll subjects previously implanted with IOLs in both eyes for at least 3&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects completed 2 visits to the investigational site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Braking Reaction Time From No-glare to Glare</measure>
    <time_frame>Visit 2, up to Day 30</time_frame>
    <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)</measure>
    <time_frame>Visit 2, Up to Day 30</time_frame>
    <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)</measure>
    <time_frame>Visit 2, Up to Day 30</time_frame>
    <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>ACRYSOF IQ IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clear IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clear IOL with or without blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clear clip-on glasses</intervention_name>
    <description>Clip-on glasses with no blue light filtering properties used as a placebo</description>
    <arm_group_label>ACRYSOF IQ IOL</arm_group_label>
    <arm_group_label>Clear IOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blue light filter clip-on glasses</intervention_name>
    <description>Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs</description>
    <arm_group_label>Clear IOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACRYSOF® IQ IOL</intervention_name>
    <description>AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted</description>
    <arm_group_label>ACRYSOF IQ IOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clear IOL</intervention_name>
    <description>Clear IOL, previously implanted</description>
    <arm_group_label>Clear IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pseudophakes with ACRYSOF® IQ monofocal IOLs or clear (no blue light filter) IOLs in&#xD;
             both eyes for at least 3 months.&#xD;
&#xD;
          -  Willing and able to understand and sign an informed consent form.&#xD;
&#xD;
          -  Corrected visual acuity (CVA) of 20/40 or better.&#xD;
&#xD;
          -  Have a valid driver's license.&#xD;
&#xD;
          -  Depth perception of at least 100 arc seconds.&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ocular pathology, degeneration, or media opacity.&#xD;
&#xD;
          -  Color vision defect.&#xD;
&#xD;
          -  Use of ocular or systemic medications that impact macular pigment density or reaction&#xD;
             time, including but not limited to, lutein, zeaxanthin, barbiturates, tranquilizers or&#xD;
             amphetamines.&#xD;
&#xD;
          -  System conditions affecting connective tissue or sensory-motor coordination.&#xD;
&#xD;
          -  Other protocol-specified exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sr Clinical Manager, GCRA-Global Med Affairs, Operations</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>February 24, 2016</results_first_submitted>
  <results_first_submitted_qc>April 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 26, 2016</results_first_posted>
  <last_update_submitted>April 20, 2016</last_update_submitted>
  <last_update_submitted_qc>April 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Intraocular lens (IOL)</keyword>
  <keyword>AcrySof</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
    <mesh_term>beta-Endorphin</mesh_term>
    <mesh_term>Adrenocorticotropic Hormone</mesh_term>
    <mesh_term>Melanocyte-Stimulating Hormones</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 6 study centers located in the US.</recruitment_details>
      <pre_assignment_details>Of the 90 enrolled, 22 subjects were exited prior to reaction testing. This reporting group includes all subjects who were reaction tested (68).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AcrySof IQ IOL</title>
          <description>ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours</description>
        </group>
        <group group_id="P2">
          <title>Clear IOL: BLF First, Then Placebo Filter</title>
          <description>Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total</description>
        </group>
        <group group_id="P3">
          <title>Clear IOL: Placebo Filter First, Then BLF</title>
          <description>Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Filter</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Filter</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all subjects who were reaction tested.</population>
      <group_list>
        <group group_id="B1">
          <title>AcrySof IQ IOL</title>
          <description>ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours</description>
        </group>
        <group group_id="B2">
          <title>Clear IOL</title>
          <description>Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total</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="33"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="68"/>
          </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="70.8" spread="3.2"/>
                    <measurement group_id="B2" value="70.3" spread="2.8"/>
                    <measurement group_id="B3" value="70.6" spread="3.0"/>
                  </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="17"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Braking Reaction Time From No-glare to Glare</title>
        <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
        <time_frame>Visit 2, up to Day 30</time_frame>
        <population>This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).</population>
        <group_list>
          <group group_id="O1">
            <title>AcrySof IQ IOL</title>
            <description>ACRYSOF® IQ IOL without filters</description>
          </group>
          <group group_id="O2">
            <title>Clear IOL</title>
            <description>Clear IOL without filters</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Braking Reaction Time From No-glare to Glare</title>
          <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
          <population>This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.12"/>
                    <measurement group_id="O2" value="0.15" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)</title>
        <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.</description>
        <time_frame>Visit 2, Up to Day 30</time_frame>
        <population>This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Filter</title>
            <description>Clear IOLs with placebo colored clip-on filters</description>
          </group>
          <group group_id="O2">
            <title>Blue Light Filter</title>
            <description>Clear IOL with clip-on glasses with blue light filtering properties</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)</title>
          <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.</description>
          <population>This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.16"/>
                    <measurement group_id="O2" value="0.16" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)</title>
        <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
        <time_frame>Visit 2, Up to Day 30</time_frame>
        <population>This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>ACRYSOF IQ IOL + Placebo Filter</title>
            <description>ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo</description>
          </group>
          <group group_id="O2">
            <title>Clear IOL + BLF</title>
            <description>Clear IOL with clip-on glasses with blue light filtering properties</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)</title>
          <description>Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.</description>
          <population>This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.12"/>
                    <measurement group_id="O2" value="0.16" spread="0.20"/>
                  </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 a subject's participation in the study (up to 30 days).</time_frame>
      <desc>An AE was defined as 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 product. AEs are reported as pre-treatment and treatment-emergent (initiation of experimental testing).</desc>
      <group_list>
        <group group_id="E1">
          <title>Pre-treatment</title>
          <description>All subjects from time to consent until initiation of experimental testing</description>
        </group>
        <group group_id="E2">
          <title>AcrySof IQ IOL</title>
          <description>All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing</description>
        </group>
        <group group_id="E3">
          <title>Clear IOL</title>
          <description>All subjects implanted with Clear IOLs from time of initiation of experimental testing</description>
        </group>
      </group_list>
      <serious_events>
        <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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </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>Global Brand Med Affairs Lead, VGR</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/NCT02219997
org study id: ILQ830-P001
nct id: NCT02219997
lead sponsor: 
has dmc: No
The purpose of this study is to compare the reaction time (as measured by braking reaction
      time in seconds during simulated driving) under glare and no-glare conditions in subjects
      implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.
      This study will enroll subjects previously implanted with IOLs in both eyes for at least 3
      months.
Subjects completed 2 visits to the investigational site.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Change in Braking Reaction Time From No-glare to Glare
time frame: Visit 2, up to Day 30
description: Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
measure: Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
time frame: Visit 2, Up to Day 30
description: Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.
measure: Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
time frame: Visit 2, Up to Day 30
description: Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.
arm group label: ACRYSOF IQ IOL
arm group type: Experimental
description: ACRYSOF® IQ IOL with or without clear clip-on glasses worn for 3 hours
arm group label: Clear IOL
arm group type: Active Comparator
description: Clear IOL with or without blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
intervention type: Device
intervention name: Clear clip-on glasses
description: Clip-on glasses with no blue light filtering properties used as a placebo
arm group label: ACRYSOF IQ IOL
arm group label: Clear IOL
intervention type: Device
intervention name: Blue light filter clip-on glasses
description: Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs
arm group label: Clear IOL
intervention type: Device
intervention name: ACRYSOF® IQ IOL
description: AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted
arm group label: ACRYSOF IQ IOL
intervention type: Device
intervention name: Clear IOL
description: Clear IOL, previously implanted
arm group label: Clear IOL
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sr Clinical Manager, GCRA-Global Med Affairs, Operations
role: Study Director
affiliation: Alcon Research
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Methamphetamine
mesh term: beta-Endorphin
mesh term: Adrenocorticotropic Hormone
mesh term: Melanocyte-Stimulating Hormones
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 