<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/NCT04495829</url>
  </required_header>
  <id_info>
    <org_study_id>ML-2020-01</org_study_id>
    <nct_id>NCT04495829</nct_id>
  </id_info>
  <brief_title>Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software</brief_title>
  <official_title>Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Corneal Consultants</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Science in Vision</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>American Corneal Consultants</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the current study is to prospectively evaluate 3-month clinical outcomes&#xD;
      from LASIK performed using the Phorcides surgical planning software with Contoura&#xD;
      topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism&#xD;
      seeking refractive surgery for distance correction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the current study is to prospectively evaluate 3-month clinical outcomes&#xD;
      from LASIK performed using the Phorcides surgical planning software with Contoura&#xD;
      topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism&#xD;
      seeking refractive surgery for distance correction. Data will be compared to published&#xD;
      results for wavefront optimized LASIK and LASIK performed with Contoura using other&#xD;
      refractive algorithms.&#xD;
&#xD;
      The hypothesis is that use of the Phorcides planning software will result in a higher&#xD;
      percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with&#xD;
      wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity&#xD;
      and visual symptoms will be improved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Actual">April 21, 2021</completion_date>
  <primary_completion_date type="Actual">April 21, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Residual Refractive Cylinder</measure>
    <time_frame>3 months postop</time_frame>
    <description>Residual refractive cylinder in diopters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Distance Visual Acuity</measure>
    <time_frame>3 months postop</time_frame>
    <description>Uncorrected visual acuity at distance (4-6m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Refractive Sphere</measure>
    <time_frame>3 months postop</time_frame>
    <description>Residual refractive spherical equivalent in diopters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction and Vision</measure>
    <time_frame>3 months postop</time_frame>
    <description>A questionnaire related to visual quality and satisfaction after surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Refractive Errors</condition>
  <arm_group>
    <arm_group_label>Phorcides</arm_group_label>
    <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phorcides Analytical Engine</intervention_name>
    <description>Surgery planning using the Phorcides analytical engine.</description>
    <arm_group_label>Phorcides</arm_group_label>
    <other_name>Phorcides</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects presenting for myopic LASIK correction who are eligible for treatment with&#xD;
        topography-guided ablation in both eyes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for Contoura excimer laser vision correction&#xD;
&#xD;
          -  Gender: males and females.&#xD;
&#xD;
          -  Age: 20 or older&#xD;
&#xD;
          -  Willing and able to provide written informed consent for participation in the study.&#xD;
&#xD;
          -  Willing and able to comply with scheduled visits and other study procedures.&#xD;
&#xD;
          -  Good ocular health, with no pathology that compromises visual acuity (other than&#xD;
             refractive error)&#xD;
&#xD;
          -  Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being&#xD;
             treated&#xD;
&#xD;
          -  Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to&#xD;
             -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D&#xD;
&#xD;
          -  Desire good vision at distance in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs'&#xD;
             dystrophy, etc.)&#xD;
&#xD;
          -  Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or&#xD;
             corneal transplant, DSAEK, DMEK, lamellar keratoplasty)&#xD;
&#xD;
          -  Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)&#xD;
&#xD;
          -  Desire for good uncorrected near vision in one or both eyes&#xD;
&#xD;
          -  Participation in (or current participation) any investigational drug or device trial&#xD;
             within the previous 30 days prior to the start date of this trial&#xD;
&#xD;
          -  Unsuitability for the trial, in the opinion of the investigator, for any reason&#xD;
&#xD;
          -  Pregnancy or desire to become pregnant during the trial&#xD;
&#xD;
          -  Intraoperative complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert D Stulting</last_name>
    <role>Principal Investigator</role>
    <affiliation>Woolfson Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Woolfson Eye Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Suburban Eye Specialists</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TLC Laser Eye Center</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser Defined Vision</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mann Eye Institute and Laser Centers</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stulting RD, Durrie DS, Potvin RJ, Linn SH, Krueger RR, Lobanoff MC, Moshirfar M, Motwani MV, Lindquist TP, Stonecipher KG. Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods. Clin Ophthalmol. 2020 Apr 24;14:1091-1100. doi: 10.2147/OPTH.S244079. eCollection 2020.</citation>
    <PMID>32425495</PMID>
  </reference>
  <results_reference>
    <citation>Lobanoff M, Stonecipher K, Tooma T, Wexler S, Potvin R. Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction. J Cataract Refract Surg. 2020 Jun;46(6):814-819. doi: 10.1097/j.jcrs.0000000000000176.</citation>
    <PMID>32176160</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <results_first_submitted>February 9, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2022</results_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</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>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04495829/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Phorcides</title>
          <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inclusion criterion not met</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phorcides</title>
          <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Only subjects competing the 3-month visit were included</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Only subjects completing the 3-month visit are included</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MRSE</title>
          <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="B1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-3.6" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Refractive cylinder</title>
          <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="B1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.54" spread=".49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Uncorrected distance VA</title>
          <units>logMAR (log of min angle of resolution</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="B1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value=".95" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corrected distance VA</title>
          <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="B1" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-.04" spread=".04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Residual Refractive Cylinder</title>
        <description>Residual refractive cylinder in diopters</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phorcides</title>
            <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Refractive Cylinder</title>
          <description>Residual refractive cylinder in diopters</description>
          <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="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Distance Visual Acuity</title>
        <description>Uncorrected visual acuity at distance (4-6m)</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phorcides</title>
            <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Distance Visual Acuity</title>
          <description>Uncorrected visual acuity at distance (4-6m)</description>
          <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="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.11" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Residual Refractive Sphere</title>
        <description>Residual refractive spherical equivalent in diopters</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phorcides</title>
            <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Refractive Sphere</title>
          <description>Residual refractive spherical equivalent in diopters</description>
          <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="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction and Vision</title>
        <description>A questionnaire related to visual quality and satisfaction after surgery</description>
        <time_frame>3 months postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phorcides</title>
            <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction and Vision</title>
          <description>A questionnaire related to visual quality and satisfaction after surgery</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Double vision</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trouble driving at night</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trouble reading</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Foreign body sensation</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fluctuation in vision</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glare</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Halos</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Light sensitivity</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Starbursts</title>
              <category_list>
                <category>
                  <title>None to moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Marked to severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Phorcides</title>
          <description>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.&#xD;
Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine.</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="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Epithelial defect</sub_title>
                <description>Epithelial defect</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>R. Doyle Stulting, MD, PhD</name_or_title>
      <organization>Woolfson Eye Institute</organization>
      <phone>(770) 255-3330</phone>
      <email>dstulting@icloud.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/NCT04495829
org study id: ML-2020-01
nct id: NCT04495829
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the current study is to prospectively evaluate 3-month clinical outcomes
      from LASIK performed using the Phorcides surgical planning software with Contoura
      topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism
      seeking refractive surgery for distance correction.
The objective of the current study is to prospectively evaluate 3-month clinical outcomes
      from LASIK performed using the Phorcides surgical planning software with Contoura
      topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism
      seeking refractive surgery for distance correction. Data will be compared to published
      results for wavefront optimized LASIK and LASIK performed with Contoura using other
      refractive algorithms.

      The hypothesis is that use of the Phorcides planning software will result in a higher
      percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with
      wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity
      and visual symptoms will be improved.
observational model: Case-Only
time perspective: Prospective
measure: Residual Refractive Cylinder
time frame: 3 months postop
description: Residual refractive cylinder in diopters
measure: Uncorrected Distance Visual Acuity
time frame: 3 months postop
description: Uncorrected visual acuity at distance (4-6m)
measure: Residual Refractive Sphere
time frame: 3 months postop
description: Residual refractive spherical equivalent in diopters
measure: Satisfaction and Vision
time frame: 3 months postop
description: A questionnaire related to visual quality and satisfaction after surgery
arm group label: Phorcides
description: Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.
intervention type: Device
intervention name: Phorcides Analytical Engine
description: Surgery planning using the Phorcides analytical engine.
arm group label: Phorcides
other name: Phorcides
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert D Stulting
role: Principal Investigator
affiliation: Woolfson Eye Institute
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Stulting RD, Durrie DS, Potvin RJ, Linn SH, Krueger RR, Lobanoff MC, Moshirfar M, Motwani MV, Lindquist TP, Stonecipher KG. Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods. Clin Ophthalmol. 2020 Apr 24;14:1091-1100. doi: 10.2147/OPTH.S244079. eCollection 2020.
PMID: 32425495
citation: Lobanoff M, Stonecipher K, Tooma T, Wexler S, Potvin R. Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction. J Cataract Refract Surg. 2020 Jun;46(6):814-819. doi: 10.1097/j.jcrs.0000000000000176.
PMID: 32176160
responsible party type: Sponsor
mesh term: Refractive Errors
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 