xml: <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/NCT06021353</url>
    </required_header>
    <id_info>
      <org_study_id>RFO268-E005</org_study_id>
      <nct_id>NCT06021353</nct_id>
    </id_info>
    <brief_title>Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation</brief_title>
    <official_title>Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation</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>
      <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 assess the WaveLight Ultraviolet Femtosecond Laser System,&#xD;
        Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed&#xD;
        WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects who qualify to participate will have both eyes treated in the study (one eye with&#xD;
        the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study&#xD;
        visits over a period of approximately 2 months. This study will be conducted outside the&#xD;
        United States.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month</measure>
      <time_frame>Month 1</time_frame>
      <description>Corneal flap thickness will be measured using optical coherence tomography (OCT)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Refractive Errors</condition>
    <arm_group>
      <arm_group_label>UV fs-Laser</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IR fs-Laser</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>UV fs-Laser</intervention_name>
      <description>Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery</description>
      <arm_group_label>UV fs-Laser</arm_group_label>
      <other_name>WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IR fs-Laser</intervention_name>
      <description>Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery</description>
      <arm_group_label>IR fs-Laser</arm_group_label>
      <other_name>WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>LASIK</intervention_name>
      <description>Laser-assisted in situ keratomileusis (LASIK) surgery</description>
      <arm_group_label>IR fs-Laser</arm_group_label>
      <arm_group_label>UV fs-Laser</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Good ocular health;&#xD;
  &#xD;
            -  Natural lens with no evidence of cataract;&#xD;
  &#xD;
            -  Eligible for LASIK;&#xD;
  &#xD;
            -  Stable refraction;&#xD;
  &#xD;
            -  Other protocol-defined inclusion criteria may apply.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of dry eye;&#xD;
  &#xD;
            -  Contraindicated systemic disease or ocular conditions;&#xD;
  &#xD;
            -  Treatment with a contraindicated medication;&#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>Principal Clinical Trial Lead, CRD Surgical</last_name>
      <role>Study Director</role>
      <affiliation>Alcon Research, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alcon Call Center</last_name>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Personaleyes</name>
        <address>
          <city>Sydney</city>
          <state>New South Wales</state>
          <zip>2000</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Laservision.gr Institute</name>
        <address>
          <city>Athens</city>
          <zip>11521</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Australia</country>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021353
  org study id: RFO268-E005
  nct id: NCT06021353
  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 assess the WaveLight Ultraviolet Femtosecond Laser System,
        Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed
        WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
  Subjects who qualify to participate will have both eyes treated in the study (one eye with
        the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study
        visits over a period of approximately 2 months. This study will be conducted outside the
        United States.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
  time frame: Month 1
  description: Corneal flap thickness will be measured using optical coherence tomography (OCT)
  arm group label: UV fs-Laser
  arm group type: Experimental
  description: First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery
  arm group label: IR fs-Laser
  arm group type: Active Comparator
  description: First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery
  intervention type: Device
  intervention name: UV fs-Laser
  description: Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
  arm group label: UV fs-Laser
  other name: WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507
  intervention type: Device
  intervention name: IR fs-Laser
  description: Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
  arm group label: IR fs-Laser
  other name: WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515
  intervention type: Procedure
  intervention name: LASIK
  description: Laser-assisted in situ keratomileusis (LASIK) surgery
  arm group label: IR fs-Laser
  arm group label: UV fs-Laser
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Principal Clinical Trial Lead, CRD Surgical
  role: Study Director
  affiliation: Alcon Research, LLC
  last name: Alcon Call Center
  phone: 1-888-451-3937
  email: alcon.medinfo@alcon.com
  facility: 
  facility: 
  country: Australia
  country: Greece
  responsible party type: Sponsor
  mesh term: Refractive Errors
  sharing ipd: No