<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/NCT01699087</url>
  </required_header>
  <id_info>
    <org_study_id>C-10-084</org_study_id>
    <nct_id>NCT01699087</nct_id>
  </id_info>
  <brief_title>A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System</brief_title>
  <official_title>Prospective Safety and Effectiveness Study of PRK for Myopia With or Without Astigmatism Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System</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 evaluate the safety and effectiveness of the ALLEGRETTO WAVE&#xD;
      EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in&#xD;
      subjects undergoing photorefractive keratectomy (PRK) treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a prospective, multi-center, single group study. Subjects underwent bilateral PRK in&#xD;
      which the second eye was treated no sooner than 1 week and no later than 30 days after the&#xD;
      first eye's PRK treatment. Subjects were followed for 2 years after surgery.&#xD;
&#xD;
      The protocol underwent 4 amendments. The key differences between the protocol versions were&#xD;
      clarifications of the planned analyses and adverse event reporting procedures. There were no&#xD;
      changes in the inclusion and exclusion criteria or non-adverse event related study&#xD;
      assessments between the protocol versions 1-5.&#xD;
&#xD;
      Refractive stability of manifest refraction spherical equivalent (MRSE) and manifest&#xD;
      refractive cylinder was defined as established when:&#xD;
&#xD;
        -  At least 95% of the treated eyes had a change ≤ 1.0 diopter between manifest refractions&#xD;
           performed at any 2 manifest refractions at least 3 months apart&#xD;
&#xD;
        -  The mean rate of change, as determined by a paired analysis, was ≤ 0.5 diopter per year&#xD;
           (0.04 D/month) over the same time period&#xD;
&#xD;
        -  The mean rate of change decreased monotonically over time, with a projected asymptote of&#xD;
           zero or a rate of change attributable to normal aging&#xD;
&#xD;
        -  The 95% confidence interval for the mean rate of change included zero or a rate of&#xD;
           change attributable to normal aging.&#xD;
&#xD;
      Refractive stability was assessed for pairs of visits within an interval and was defined to&#xD;
      occur at the latter time point of the first interval at which stability was achieved.&#xD;
&#xD;
      In the final amendment to the protocol, 3 secondary objectives were made co-primary in&#xD;
      response to Agency comments. All endpoints and analyses were modified to match.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits</measure>
    <time_frame>Up to Month 24 (post second eye surgery)</time_frame>
    <description>MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Incidence of Ocular Serious Adverse Events by Eye</measure>
    <time_frame>Up to Month 24 (post second eye surgery)</time_frame>
    <description>Participants were followed for the duration of the study, an expected average of 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes With &gt; 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability</measure>
    <time_frame>Month 6 (post second eye surgery)</time_frame>
    <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>PRK ALLEGRETTO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Photorefractive keratectomy (PRK)</intervention_name>
    <description>In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.</description>
    <arm_group_label>PRK ALLEGRETTO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ALLEGRETTO WAVE EYE-Q excimer laser system</intervention_name>
    <description>The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery</description>
    <arm_group_label>PRK ALLEGRETTO</arm_group_label>
    <other_name>ALLEGRETTO WAVE Eye-Q</other_name>
    <other_name>WaveLight® EX500</other_name>
    <other_name>WaveNet™ Planning Software</other_name>
    <other_name>ALLEGRETTO WAVE® EYE-Q excimer laser system (Model 1010-3)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects desiring refractive correction of myopia up to -6.00 Diopter (D) sphere with&#xD;
             or without astigmatism 0 to -3.00 D and up to -6.00 D manifest refraction spherical&#xD;
             equivalent (MRSE) at the spectacle plane measured by manifest refraction;&#xD;
&#xD;
          -  Minimum best spectacle corrected visual acuity (BSCVA) in the treated eye of 20/25;&#xD;
&#xD;
          -  Uncorrected visual acuity (UCVA) 20/40 or worse in the treated eye;&#xD;
&#xD;
          -  Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest&#xD;
             refractions;&#xD;
&#xD;
          -  Stable refraction (within ± 0.5 D), as determined by MRSE for a minimum of 12 months&#xD;
             prior to surgery;&#xD;
&#xD;
          -  Demonstrated stable refraction for contact lens wearers, as specified in protocol;&#xD;
&#xD;
          -  Signed informed consent document;&#xD;
&#xD;
          -  Willing and able to comply with schedule for follow-up visits;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Females who are pregnant, lactating, or planning a pregnancy during the time course of&#xD;
             the study, or have another condition associated with the fluctuation of hormones that&#xD;
             could lead to refractive changes;&#xD;
&#xD;
          -  Participation in other clinical trials during this study;&#xD;
&#xD;
          -  Acute or chronic disease or illness that would increase the operative risk or confound&#xD;
             the outcomes of the study;&#xD;
&#xD;
          -  Dry eye syndrome as determined by the short questionnaire for dry eye syndrome;&#xD;
&#xD;
          -  Systemic medications that may confound the outcome of the study or increase the risk&#xD;
             to the subject by affecting wound healing or tissue repair, including, but not limited&#xD;
             to steroids, antimetabolites, immune response modifying drugs, etc.;&#xD;
&#xD;
          -  Nystagmus or any other condition that would prevent a steady gaze during the PRK&#xD;
             treatment or other diagnostic tests;&#xD;
&#xD;
          -  Ocular condition that may predispose the subject to future complications;&#xD;
&#xD;
          -  Previous intraocular or corneal surgery;&#xD;
&#xD;
          -  Subjects who desire to have monovision;&#xD;
&#xD;
          -  A known sensitivity to medications used for study procedures, including PRK;&#xD;
&#xD;
          -  Presence or history of any condition or finding that makes the subject unsuitable as a&#xD;
             candidate for PRK or study participation or may confound the outcome of the study, in&#xD;
             the opinion of the Investigator;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sr. Clinical Manager, GCRA Surgical</last_name>
    <role>Study Director</role>
    <affiliation>Alcon, a Novartis Company</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>January 3, 2017</results_first_submitted>
  <results_first_submitted_qc>February 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 10, 2017</results_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PRK</keyword>
  <keyword>myopia</keyword>
  <keyword>astigmatism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 8 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>Of the 176 participants enrolled, 15 did not meet inclusion and exclusion criteria and were exited prior to treatment as screen failures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PRK ALLEGRETTO</title>
          <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure (prior to treatment)</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to make future visits</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all enrolled subjects who underwent PRK surgery (intent-to-treat).</population>
      <group_list>
        <group group_id="B1">
          <title>PRK ALLEGRETTO</title>
          <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="161"/>
          </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="31.5" spread="7.4"/>
                  </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="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                  </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="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively</title>
        <description>Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>Intent to treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively</title>
          <description>Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.</description>
          <population>Intent to treat (ITT)</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability</title>
        <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability</title>
          <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability</title>
        <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability</title>
          <description>Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability</title>
        <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability</title>
          <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability</title>
        <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability</title>
          <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits</title>
        <description>MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
        <time_frame>Up to Month 24 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits</title>
          <description>MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 to Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 to Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="317"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 to Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="310"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 to Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cumulative Incidence of Ocular Serious Adverse Events by Eye</title>
        <description>Participants were followed for the duration of the study, an expected average of 24 months.</description>
        <time_frame>Up to Month 24 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Incidence of Ocular Serious Adverse Events by Eye</title>
          <description>Participants were followed for the duration of the study, an expected average of 24 months.</description>
          <population>ITT</population>
          <units>eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corneal infiltrates</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal oedema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability</title>
        <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability</title>
          <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability</title>
        <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability</title>
          <description>Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With &gt; 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability</title>
        <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.</description>
        <time_frame>Month 6 (post second eye surgery)</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>PRK ALLEGRETTO</title>
            <description>Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With &gt; 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability</title>
          <description>Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.</description>
          <population>ITT</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent.</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 medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pre-treatment</title>
          <description>All subjects who consented to participate in the study prior to the initiation of study treatment</description>
        </group>
        <group group_id="E2">
          <title>PRK ALLEGRETTO</title>
          <description>All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation</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="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal infiltrates</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Meniscus lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="176"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal opacity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Foreign body sensation in eyes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="161"/>
              </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>Expert Clinical Project Lead, GCRA, Surgical</name_or_title>
      <organization>Alcon, A Novartis Division</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/NCT01699087
org study id: C-10-084
nct id: NCT01699087
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE
      EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in
      subjects undergoing photorefractive keratectomy (PRK) treatment.
This was a prospective, multi-center, single group study. Subjects underwent bilateral PRK in
      which the second eye was treated no sooner than 1 week and no later than 30 days after the
      first eye's PRK treatment. Subjects were followed for 2 years after surgery.

      The protocol underwent 4 amendments. The key differences between the protocol versions were
      clarifications of the planned analyses and adverse event reporting procedures. There were no
      changes in the inclusion and exclusion criteria or non-adverse event related study
      assessments between the protocol versions 1-5.

      Refractive stability of manifest refraction spherical equivalent (MRSE) and manifest
      refractive cylinder was defined as established when:

        -  At least 95% of the treated eyes had a change ≤ 1.0 diopter between manifest refractions
           performed at any 2 manifest refractions at least 3 months apart

        -  The mean rate of change, as determined by a paired analysis, was ≤ 0.5 diopter per year
           (0.04 D/month) over the same time period

        -  The mean rate of change decreased monotonically over time, with a projected asymptote of
           zero or a rate of change attributable to normal aging

        -  The 95% confidence interval for the mean rate of change included zero or a rate of
           change attributable to normal aging.

      Refractive stability was assessed for pairs of visits within an interval and was defined to
      occur at the latter time point of the first interval at which stability was achieved.

      In the final amendment to the protocol, 3 secondary objectives were made co-primary in
      response to Agency comments. All endpoints and analyses were modified to match.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively
time frame: Month 6 (post second eye surgery)
description: Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.
measure: Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
measure: Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
measure: Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
measure: Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
measure: Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits
time frame: Up to Month 24 (post second eye surgery)
description: MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
measure: Cumulative Incidence of Ocular Serious Adverse Events by Eye
time frame: Up to Month 24 (post second eye surgery)
description: Participants were followed for the duration of the study, an expected average of 24 months.
measure: Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).
measure: Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .
measure: Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability
time frame: Month 6 (post second eye surgery)
description: Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.
arm group label: PRK ALLEGRETTO
arm group type: Experimental
description: Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
intervention type: Procedure
intervention name: Photorefractive keratectomy (PRK)
description: In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.
arm group label: PRK ALLEGRETTO
intervention type: Device
intervention name: ALLEGRETTO WAVE EYE-Q excimer laser system
description: The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery
arm group label: PRK ALLEGRETTO
other name: ALLEGRETTO WAVE Eye-Q
other name: WaveLight® EX500
other name: WaveNet™ Planning Software
other name: ALLEGRETTO WAVE® EYE-Q excimer laser system (Model 1010-3)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. Clinical Manager, GCRA Surgical
role: Study Director
affiliation: Alcon, a Novartis Company
responsible party type: Sponsor
mesh term: Myopia
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 