<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/NCT01675492</url>
  </required_header>
  <id_info>
    <org_study_id>STAR-112-IDMA</org_study_id>
    <nct_id>NCT01675492</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism</brief_title>
  <official_title>A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and&#xD;
      effective in the treatment of mixed astigmatism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2012</start_date>
  <completion_date type="Actual">November 22, 2016</completion_date>
  <primary_completion_date type="Actual">November 22, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)</measure>
    <time_frame>3 Months</time_frame>
    <description>&lt; 5% of eyes will have a loss of &gt; 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Visual Acuity (UCVA) of 20/40 or Better</measure>
    <time_frame>3 Months</time_frame>
    <description>85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>wave-front guided LASIK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LASIK</intervention_name>
    <description>Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System</description>
    <arm_group_label>wave-front guided LASIK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age at the time of pre-operative exam&#xD;
&#xD;
          -  Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better&#xD;
&#xD;
          -  Demonstration of refractive stability&#xD;
&#xD;
          -  Anticipated post-operative stromal bed thickness of at lest 250 microns&#xD;
&#xD;
          -  Willing and capable of returning for follow-up examinations for the duration of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, breast-feeding, or intend to become pregnant over the course&#xD;
             of the study&#xD;
&#xD;
          -  Concurrent use of topical or systemic medications that may impair healing&#xD;
&#xD;
          -  History of any medical conditions that could affect wound healing&#xD;
&#xD;
          -  History of prior intraocular or corneal surgery, active ophthalmic disease,or other&#xD;
             ocular abnormality&#xD;
&#xD;
          -  Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative&#xD;
             eye(s)&#xD;
&#xD;
          -  Known sensitivity or inappropriate responsiveness to any of the medications used in&#xD;
             the post-operative course&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kendra Hileman, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Optics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univerisity of Miami Bascom Palmer Eye Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kraff Eye Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepose Vision Institute</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017-5065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durrie Vision</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coleman Vision</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehmann Eye Center</name>
      <address>
        <city>Nacogdoches</city>
        <state>Texas</state>
        <zip>75965</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Center</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King LASIK</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>February 3, 2017</results_first_submitted>
  <results_first_submitted_qc>May 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 30, 2017</results_first_posted>
  <last_update_submitted>May 23, 2017</last_update_submitted>
  <last_update_submitted_qc>May 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Astigmatism</keyword>
  <keyword>refractive</keyword>
  <keyword>error</keyword>
  <keyword>LASIK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wave-front Guided LASIK</title>
          <description>Vision correction for a mixed astigmatism refraction</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>study completed early - product approval</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wave-front Guided LASIK</title>
          <description>LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="84"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="149"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.3" spread="10.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)</title>
        <description>&lt; 5% of eyes will have a loss of &gt; 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters</description>
        <time_frame>3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wave-front Guided LASIK</title>
            <description>LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction</description>
          </group>
        </group_list>
        <measure>
          <title>Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)</title>
          <description>&lt; 5% of eyes will have a loss of &gt; 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters</description>
          <units>eyes</units>
          <param>Count of Units</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Visual Acuity (UCVA) of 20/40 or Better</title>
        <description>85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters</description>
        <time_frame>3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wave-front Guided LASIK</title>
            <description>LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Visual Acuity (UCVA) of 20/40 or Better</title>
          <description>85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters</description>
          <units>eyes</units>
          <param>Count of Units</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wave-front Guided LASIK</title>
          <description>LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="84"/>
              </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="84"/>
              </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>The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Operations</name_or_title>
      <organization>Abbott Medical Optics</organization>
      <phone>714-247-8628</phone>
      <email>lachelle.arredondo@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/NCT01675492
org study id: STAR-112-IDMA
nct id: NCT01675492
lead sponsor: 
has dmc: No
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and
      effective in the treatment of mixed astigmatism.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
time frame: 3 Months
description: < 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
measure: Uncorrected Visual Acuity (UCVA) of 20/40 or Better
time frame: 3 Months
description: 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
arm group label: wave-front guided LASIK
arm group type: Experimental
intervention type: Device
intervention name: LASIK
description: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
arm group label: wave-front guided LASIK
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kendra Hileman, PhD
role: Study Director
affiliation: Abbott Medical Optics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 