<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/NCT02203747</url>
  </required_header>
  <id_info>
    <org_study_id>TIOL-201-VPAS</org_study_id>
    <nct_id>NCT02203747</nct_id>
  </id_info>
  <brief_title>Patient Perception of Visual Distortions</brief_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 study is to evaluate visual distortions reported by pseudophakic&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Distortion Symptoms</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Distortion Symptoms</measure>
    <time_frame>1 week</time_frame>
    <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Cataract</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>Pseudophakic implanted with toric IOL</arm_group_label>
    <description>Subjects bilaterally implanted with toric IOL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pseudophakic implanted with non-toric IOL</arm_group_label>
    <description>Subjects bilaterally implanted with non-toric IOL</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Administration of patient self-assessment</intervention_name>
    <arm_group_label>Pseudophakic implanted with non-toric IOL</arm_group_label>
    <arm_group_label>Pseudophakic implanted with toric IOL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Bilaterally-implanted pseudophakic subjects over 22 years of age with astigmatism who meet&#xD;
        the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Corneal astigmatism of at least 0.75 diopters&#xD;
&#xD;
          -  Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with&#xD;
             monofocal non-toric intraocular lenses in both eyes&#xD;
&#xD;
          -  At least one month postoperative from second-eye surgery&#xD;
&#xD;
          -  Ability to understand, read and write English to give consent and complete study&#xD;
             questionnaire&#xD;
&#xD;
          -  Availability, willingness, and sufficient cognitive awareness to comply with&#xD;
             examination procedures and study visits&#xD;
&#xD;
          -  Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA)&#xD;
             authorization&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any ocular pathology of clinical significance, as determined by the investigator,&#xD;
             other than regular corneal astigmatism, that may affect visual outcomes or influence&#xD;
             subjective ocular visual symptoms&#xD;
&#xD;
          -  Patient is pregnant or is lactating&#xD;
&#xD;
          -  Participation in any other clinical trial during the last 30 days prior to study&#xD;
             enrollment or concurrent participation in any other ongoing clinical trial&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Contact AMO for Trial Locations</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>September 30, 2015</results_first_submitted>
  <results_first_submitted_qc>November 18, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 22, 2015</results_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pseudophakic Implanted With Toric IOL</title>
          <description>Subjects implanted with bilateral toric IOL&#xD;
Administration of patient self-assessment</description>
        </group>
        <group group_id="P2">
          <title>Pseudophakic Implanted With Non-toric IOL</title>
          <description>Subjects implanted with bilateral non-toric IOL&#xD;
Administration of patient self-assessment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="34"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Pseudophakic Implanted With Toric IOL</title>
          <description>Subjects implanted with bilateral toric IOL&#xD;
Administration of patient self-assessment</description>
        </group>
        <group group_id="B2">
          <title>Pseudophakic Implanted With Non-toric IOL</title>
          <description>Subjects implanted with bilateral non-toric IOL&#xD;
Administration of patient self-assessment</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="45"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Total participants in the &quot;Pseudophakic implanted with toric IOL&quot; group is 45, but age was not reported for one subject.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="71.39" spread="8.34"/>
                    <measurement group_id="B2" value="69.68" spread="11.08"/>
                    <measurement group_id="B3" value="70.64" spread="9.59"/>
                  </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="23"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="38"/>
                  </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="45"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Distortion Symptoms</title>
        <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
        <time_frame>Baseline</time_frame>
        <population>Of the 45 subjects in the &quot;Pseudophakic implanted with toric IOL&quot; group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion).</population>
        <group_list>
          <group group_id="O1">
            <title>Pseudophakic Implanted With Toric IOL</title>
            <description>Subjects implanted with toric IOL&#xD;
Administration of patient self-assessment</description>
          </group>
          <group group_id="O2">
            <title>Pseudophakic Implanted With Non-toric IOL</title>
            <description>Subjects implanted with non-toric IOL&#xD;
Administration of patient self-assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Distortion Symptoms</title>
          <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
          <population>Of the 45 subjects in the &quot;Pseudophakic implanted with toric IOL&quot; group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion).</population>
          <units>rating of visual distortion symptoms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lines that tilt/slant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="1.13"/>
                    <measurement group_id="O2" value="0.38" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flat surfaces appear curved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.97"/>
                    <measurement group_id="O2" value="0.38" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>objects appear further away/closer than they are</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.78"/>
                    <measurement group_id="O2" value="0.56" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Objects have different size/shape</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.99"/>
                    <measurement group_id="O2" value="0.62" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>physical discomfort related to vision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.90"/>
                    <measurement group_id="O2" value="0.56" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Distortion Symptoms</title>
        <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
        <time_frame>1 week</time_frame>
        <population>Of the 45 subjects in the &quot;Pseudophakic implanted with toric IOL&quot; group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval).</population>
        <group_list>
          <group group_id="O1">
            <title>Pseudophakic Implanted With Toric IOL</title>
            <description>Subjects implanted with toric IOL&#xD;
Administration of patient self-assessment</description>
          </group>
          <group group_id="O2">
            <title>Pseudophakic Implanted With Non-toric IOL</title>
            <description>Subjects implanted with non-toric IOL&#xD;
Administration of patient self-assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Distortion Symptoms</title>
          <description>Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: &quot;did not experience&quot; (rating = 0), &quot;mild&quot; (rating = 1), &quot;moderate&quot; (rating = 2), or &quot;severe&quot; (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.</description>
          <population>Of the 45 subjects in the &quot;Pseudophakic implanted with toric IOL&quot; group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval).</population>
          <units>rating of visual distortion symptoms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lines that tilt/slant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.95"/>
                    <measurement group_id="O2" value="0.65" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flat surfaces appear curved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.87"/>
                    <measurement group_id="O2" value="0.38" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>objects appear further away/closer than they are</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.78"/>
                    <measurement group_id="O2" value="0.47" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Objects have different size/shape</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.84"/>
                    <measurement group_id="O2" value="0.47" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>physical discomfort related to vision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.92"/>
                    <measurement group_id="O2" value="0.47" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pseudophakic Implanted With Toric IOL</title>
          <description>Subjects implanted with toric IOL&#xD;
Administration of patient self-assessment</description>
        </group>
        <group group_id="E2">
          <title>Pseudophakic Implanted With Non-toric IOL</title>
          <description>Subjects implanted with non-toric IOL&#xD;
Administration of patient self-assessment</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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Achiness and pressure</sub_title>
                <description>Subject experienced achiness and eye pressure after experiencing a lupus flare-up, unrelated to study procedure.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Headache with dizziness and nausea</sub_title>
                <description>Subject reported feeling nausea with a headache and dizziness hours after astigmatism induction</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </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>Clinical Trial Agreement</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Carrie Garufis</name_or_title>
      <organization>Abbott Medical Optics</organization>
      <phone>714-566-3728</phone>
      <email>carrie.garufis@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/NCT02203747
org study id: TIOL-201-VPAS
nct id: NCT02203747
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate visual distortions reported by pseudophakic
      patients.
observational model: Case-Control
time perspective: Prospective
measure: Visual Distortion Symptoms
time frame: Baseline
description: Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
measure: Visual Distortion Symptoms
time frame: 1 week
description: Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.
arm group label: Pseudophakic implanted with toric IOL
description: Subjects bilaterally implanted with toric IOL
arm group label: Pseudophakic implanted with non-toric IOL
description: Subjects bilaterally implanted with non-toric IOL
intervention type: Other
intervention name: Administration of patient self-assessment
arm group label: Pseudophakic implanted with non-toric IOL
arm group label: Pseudophakic implanted with toric IOL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 