<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/NCT01663363</url>
  </required_header>
  <id_info>
    <org_study_id>STAR-110-IDMY</org_study_id>
    <nct_id>NCT01663363</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors</brief_title>
  <official_title>A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and&#xD;
      effective for the correction of myopic refractive errors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 3</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>Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>wavefront-guided LASIK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LASIK correction of myopic refractive errors</intervention_name>
    <description>Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System</description>
    <arm_group_label>wavefront-guided LASIK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or greater&#xD;
&#xD;
          -  Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better&#xD;
&#xD;
          -  Uncorrected visual acuity (UCVA) of 20/40 or worse&#xD;
&#xD;
          -  Less than 0.75D difference between cycloplegic and manifest refraction sphere.&#xD;
&#xD;
          -  Demonstration of refractive stability&#xD;
&#xD;
          -  Anticipated post-operative stromal bed thickness of at least 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>Contact Abbott Medical Optics for locations</name>
      <address>
        <city>Milpitas</city>
        <state>California</state>
        <zip>95035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>May 28, 2015</results_first_submitted>
  <results_first_submitted_qc>June 9, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 26, 2015</results_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>refractive</keyword>
  <keyword>LASIK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>334 eyes were treated among 170 participants.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Wavefront-guided LASIK</title>
          <description>LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="170">334 Eyes were treated among 170 participants</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="170">334 Eyes were treated among 170 participants</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The number of participants is 170, but 334 eyes were evaluated among these 170 participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Wavefront-guided LASIK</title>
          <description>LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="170"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </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="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)</title>
        <time_frame>6 Months</time_frame>
        <population>Data from 334 eyes of 170 participants are included for the outcome measure &quot;Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)&quot;.</population>
        <group_list>
          <group group_id="O1">
            <title>Wavefront-guided LASIK</title>
            <description>LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)</title>
          <population>Data from 334 eyes of 170 participants are included for the outcome measure &quot;Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)&quot;.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Confidence intervals were not calculated because 0% of eyes lost more than 2 lines of BSCVA.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better</title>
        <time_frame>6 Months</time_frame>
        <population>Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure &quot;Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better&quot;.</population>
        <group_list>
          <group group_id="O1">
            <title>Wavefront-guided LASIK</title>
            <description>LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better</title>
          <population>Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure &quot;Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better&quot;.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="96.1" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wavefront-guided LASIK</title>
          <description>LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="334"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Primary open angle glaucoma</sub_title>
                <description>Protocol defines primary open angle glaucoma as a serious adverse event.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="334"/>
              </event>
              <event>
                <sub_title>Transient light sensitivity syndrome</sub_title>
                <description>Protocol defines transient light sensitivity syndrome as a serious adverse event</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="334"/>
              </event>
              <event>
                <sub_title>Melting of the flap</sub_title>
                <description>Protocol defines melting of the flap as a serious adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="334"/>
              </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="334"/>
              </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 agreement between the Principal Investigator and the Sponsor (or its agents) restricts the PI's rights to discuss or publish trial results until after the trial is completed and requires prior approval from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ann Murphy, Manager, Clinical Research</name_or_title>
      <organization>Abbott Medical Optics</organization>
      <phone>619-518-4158</phone>
      <email>Ann.Murphy@abbott.org</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/NCT01663363
org study id: STAR-110-IDMY
nct id: NCT01663363
lead sponsor: 
has dmc: No
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and
      effective for the correction of myopic refractive errors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
time frame: 6 Months
measure: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
time frame: 6 Months
arm group label: wavefront-guided LASIK
arm group type: Experimental
description: LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
intervention type: Device
intervention name: LASIK correction of myopic refractive errors
description: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
arm group label: wavefront-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: 
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 