<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/NCT01673503</url>
  </required_header>
  <id_info>
    <org_study_id>S-20100111</org_study_id>
    <nct_id>NCT01673503</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Femtosecond Laser Intracorneal Lensectomi</brief_title>
  <official_title>A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare visual acuity, safety, predictability, corneal&#xD;
      biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule&#xD;
      extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after&#xD;
      ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <phase>Phase 3</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>refractive predictability</measure>
    <time_frame>Pre-surgery, 1 week, 1 month, 3 months, 6 months</time_frame>
    <description>Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Corneal biomechanics, corneal nerve changes and dry eye symptoms</measure>
    <time_frame>pre-surgery and 6 months after</time_frame>
    <description>Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment>35</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>Carl Zeiss Meditech VisuMax laser - ReLEx flex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>&gt;30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carl Zeiss Meditech VisuMax laser - ReLEx smile</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>&gt;30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Carl Zeiss Meditech VisuMax laser</intervention_name>
    <description>Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser</description>
    <arm_group_label>Carl Zeiss Meditech VisuMax laser - ReLEx flex</arm_group_label>
    <arm_group_label>Carl Zeiss Meditech VisuMax laser - ReLEx smile</arm_group_label>
    <other_name>Refractive lenticule extraction, ReLEx</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  25 to 45 years,&#xD;
&#xD;
          -  moderate to high myopia with astigmatism =&lt; 2 D,&#xD;
&#xD;
          -  otherwise eye healthy,&#xD;
&#xD;
          -  CDVA of 0.8 or better (Snellen).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic or ocular disease or previous eye surgery,&#xD;
&#xD;
          -  thin cornea,&#xD;
&#xD;
          -  a difference of more than 2 D myopia in the eyes of each subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders H Vestergaard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital, University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>January 23, 2013</last_update_submitted>
  <last_update_submitted_qc>January 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Anders H. Vestergaard</investigator_full_name>
    <investigator_title>MD, PhD student</investigator_title>
  </responsible_party>
  <keyword>Myopia</keyword>
  <keyword>refractive surgery</keyword>
  <keyword>all femtosecond laser</keyword>
  <keyword>ReLEx flex</keyword>
  <keyword>ReLEx smile</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01673503
org study id: S-20100111
nct id: NCT01673503
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare visual acuity, safety, predictability, corneal
      biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule
      extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after
      ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual acuity
time frame: up to 6 months
description: Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
measure: refractive predictability
time frame: Pre-surgery, 1 week, 1 month, 3 months, 6 months
description: Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability
measure: Corneal biomechanics, corneal nerve changes and dry eye symptoms
time frame: pre-surgery and 6 months after
description: Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.
arm group label: Carl Zeiss Meditech VisuMax laser - ReLEx flex
arm group type: Active Comparator
description: >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
arm group label: Carl Zeiss Meditech VisuMax laser - ReLEx smile
arm group type: Active Comparator
description: >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
intervention type: Device
intervention name: Carl Zeiss Meditech VisuMax laser
description: Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
arm group label: Carl Zeiss Meditech VisuMax laser - ReLEx flex
arm group label: Carl Zeiss Meditech VisuMax laser - ReLEx smile
other name: Refractive lenticule extraction, ReLEx
criteria: 
gender: All
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anders H Vestergaard, MD
role: Principal Investigator
affiliation: Odense University Hospital, University of Southern Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Anders H. Vestergaard
investigator title: MD, PhD student
mesh term: Myopia
mesh term: Astigmatism