<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/NCT02987660</url>
  </required_header>
  <id_info>
    <org_study_id>RFL605-P001</org_study_id>
    <nct_id>NCT02987660</nct_id>
  </id_info>
  <brief_title>Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax</brief_title>
  <official_title>Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon, a Novartis Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis&#xD;
      (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for&#xD;
      the treatment of myopia with astigmatism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    management decision; non patient safety related reason&#xD;
  </why_stopped>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">July 26, 2017</completion_date>
  <primary_completion_date type="Actual">July 26, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months</measure>
    <time_frame>Month 3</time_frame>
    <description>Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Manifest Refraction Cylinder at 3 Months</measure>
    <time_frame>Month 3</time_frame>
    <description>Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Uncorrected Visual Acuity (UCVA) at 3 Months</measure>
    <time_frame>Month 3</time_frame>
    <description>Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in &quot;logarithm of the minimum angle of resolution&quot; (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>LASIK with EX500</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMILE with VisuMax</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Topography Guided LASIK</intervention_name>
    <description>Corneal surgery for refractive error correction</description>
    <arm_group_label>LASIK with EX500</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Small Incision Lenticular Extraction</intervention_name>
    <description>Refractive surgical procedure for the correction of myopia with or without astigmatism</description>
    <arm_group_label>SMILE with VisuMax</arm_group_label>
    <other_name>SMILE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WaveLight EX500 Excimer Laser System</intervention_name>
    <description>As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.</description>
    <arm_group_label>LASIK with EX500</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VisuMax Surgical Laser</intervention_name>
    <description>As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.</description>
    <arm_group_label>SMILE with VisuMax</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects in Singapore must be 21 years of age or older and subjects in Korea must be&#xD;
             upon completion of 19 years of age or older due to local regulations;&#xD;
&#xD;
          -  Able to comprehend and sign an informed consent form;&#xD;
&#xD;
          -  Willing and able to complete all postoperative visits;&#xD;
&#xD;
          -  Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity&#xD;
             adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D&#xD;
             manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.&#xD;
&#xD;
          -  Intended treatment targeted for emmetropia;&#xD;
&#xD;
          -  Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating, current or planned, during the course of the study;&#xD;
&#xD;
          -  Dry eye;&#xD;
&#xD;
          -  Corneal disease;&#xD;
&#xD;
          -  Diagnosis of advanced glaucoma;&#xD;
&#xD;
          -  Uncontrolled diabetes;&#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>Alcon, A Novartis Division</last_name>
    <role>Study Director</role>
    <affiliation>Alcon, A Novartis Division</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>July 9, 2018</results_first_submitted>
  <results_first_submitted_qc>July 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 14, 2019</results_first_posted>
  <last_update_submitted>July 9, 2018</last_update_submitted>
  <last_update_submitted_qc>July 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02987660/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02987660/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 1 study center located in France.</recruitment_details>
      <pre_assignment_details>Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LASIK</title>
          <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
        </group>
        <group group_id="P2">
          <title>SMILE</title>
          <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all eyes of randomized subjects for whom the treatment was initiated (Intent to treat Analysis Set) (ITT).</population>
      <group_list>
        <group group_id="B1">
          <title>LASIK</title>
          <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
        </group>
        <group group_id="B2">
          <title>SMILE</title>
          <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_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="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months</title>
        <description>Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
        <time_frame>Month 3</time_frame>
        <population>ITT with non-missing data</population>
        <group_list>
          <group group_id="O1">
            <title>LASIK</title>
            <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
          </group>
          <group group_id="O2">
            <title>SMILE</title>
            <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months</title>
          <description>Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
          <population>ITT with non-missing data</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="26.2" upper_limit="87.8"/>
                    <measurement group_id="O2" value="100.0" lower_limit="76.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Manifest Refraction Cylinder at 3 Months</title>
        <description>Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
        <time_frame>Month 3</time_frame>
        <population>ITT with non-missing data</population>
        <group_list>
          <group group_id="O1">
            <title>LASIK</title>
            <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
          </group>
          <group group_id="O2">
            <title>SMILE</title>
            <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Manifest Refraction Cylinder at 3 Months</title>
          <description>Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.</description>
          <population>ITT with non-missing data</population>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.575" spread="0.4091"/>
                    <measurement group_id="O2" value="-0.232" spread="0.1539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Uncorrected Visual Acuity (UCVA) at 3 Months</title>
        <description>Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in &quot;logarithm of the minimum angle of resolution&quot; (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.</description>
        <time_frame>Month 3</time_frame>
        <population>ITT with non-missing data</population>
        <group_list>
          <group group_id="O1">
            <title>LASIK</title>
            <description>Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
          </group>
          <group group_id="O2">
            <title>SMILE</title>
            <description>Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Uncorrected Visual Acuity (UCVA) at 3 Months</title>
          <description>Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in &quot;logarithm of the minimum angle of resolution&quot; (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.</description>
          <population>ITT with non-missing data</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.100" spread="0.1360"/>
                    <measurement group_id="O2" value="-0.164" spread="0.0769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Surgery through study completion, an average of 3 months, per the early termination criteria.</time_frame>
      <desc>An adverse event (AE) is 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 through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>LASIK</title>
          <description>Subjects exposed to topography guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery</description>
        </group>
        <group group_id="E2">
          <title>SMILE</title>
          <description>Subjects exposed to SMILE with VisuMax laser in bilateral surgery</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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>Sr. Global Brand Medical Affairs Lead, CDMA 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/NCT02987660
org study id: RFL605-P001
nct id: NCT02987660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis
      (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for
      the treatment of myopia with astigmatism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
time frame: Month 3
description: Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
measure: Mean Manifest Refraction Cylinder at 3 Months
time frame: Month 3
description: Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
measure: Mean Uncorrected Visual Acuity (UCVA) at 3 Months
time frame: Month 3
description: Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.
arm group label: LASIK with EX500
arm group type: Experimental
description: Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
arm group label: SMILE with VisuMax
arm group type: Active Comparator
description: Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
intervention type: Procedure
intervention name: Topography Guided LASIK
description: Corneal surgery for refractive error correction
arm group label: LASIK with EX500
intervention type: Procedure
intervention name: Small Incision Lenticular Extraction
description: Refractive surgical procedure for the correction of myopia with or without astigmatism
arm group label: SMILE with VisuMax
other name: SMILE
intervention type: Device
intervention name: WaveLight EX500 Excimer Laser System
description: As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
arm group label: LASIK with EX500
intervention type: Device
intervention name: VisuMax Surgical Laser
description: As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
arm group label: SMILE with VisuMax
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alcon, A Novartis Division
role: Study Director
affiliation: Alcon, A Novartis Division
facility: 
country: France
responsible party type: Sponsor
mesh term: Astigmatism
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 