<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/NCT01682434</url>
  </required_header>
  <id_info>
    <org_study_id>AUH_LASIK</org_study_id>
    <nct_id>NCT01682434</nct_id>
  </id_info>
  <brief_title>Wavefront-guided LASIK for Correction of Myopia</brief_title>
  <official_title>Wavefront-guided LASIK for Correction of Myopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate&#xD;
      myopia.&#xD;
&#xD;
      Advances over the last decade have allowed LASIK to also correct higher order wavefront&#xD;
      aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided&#xD;
      treatment. However, it remains to be established whether there is a beneficial effect in&#xD;
      higher degrees of myopia.&#xD;
&#xD;
      The study aims to determine whether myopic subjects (-6 to -10 diopters) with&#xD;
      higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided&#xD;
      treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional&#xD;
      treatment in the other.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Institution changed surgical method to small-incision lenticule extraction. Study never&#xD;
    started.&#xD;
  </why_stopped>
  <start_date>May 2011</start_date>
  <primary_completion_date type="Actual">January 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular higher order aberrations</measure>
    <time_frame>12 months</time_frame>
    <description>Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Wavefront-guided LASIK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional LASIK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser in situ keratomileusis (LASIK)</intervention_name>
    <description>Wavefront guided treatment in one eye, conventional in the other.</description>
    <arm_group_label>Conventional LASIK</arm_group_label>
    <arm_group_label>Wavefront-guided LASIK</arm_group_label>
    <other_name>Device: Carl Zeiss Meditec Visumax femtosecond LASIK</other_name>
    <other_name>Device: Carl Zeiss Meditec MEL-80 excimer laser.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 to 50 years&#xD;
&#xD;
          -  No known ocular or systemic disease&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
          -  Myopia between -6.0 and -10.0 diopters&#xD;
&#xD;
          -  Astigmatism below 2.0 diopters&#xD;
&#xD;
          -  Difference of less than 1.0 diopters in spherical equivalent between eyes&#xD;
&#xD;
          -  Normal corneal topography&#xD;
&#xD;
          -  Corneal thickness sufficient for planned treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that do not fulfill inclusion criteria&#xD;
&#xD;
          -  Insufficient quality of ocular wavefront measurement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Ivarsen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>April 30, 2014</last_update_submitted>
  <last_update_submitted_qc>April 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Anders Ivarsen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT01682434
org study id: AUH_LASIK
nct id: NCT01682434
lead sponsor: 
has dmc: No
Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate
      myopia.

      Advances over the last decade have allowed LASIK to also correct higher order wavefront
      aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided
      treatment. However, it remains to be established whether there is a beneficial effect in
      higher degrees of myopia.

      The study aims to determine whether myopic subjects (-6 to -10 diopters) with
      higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided
      treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional
      treatment in the other.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual acuity
time frame: 12 months
measure: Ocular higher order aberrations
time frame: 12 months
description: Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA
arm group label: Wavefront-guided LASIK
arm group type: Active Comparator
description: One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.
arm group label: Conventional LASIK
arm group type: Active Comparator
description: One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.
intervention type: Procedure
intervention name: Laser in situ keratomileusis (LASIK)
description: Wavefront guided treatment in one eye, conventional in the other.
arm group label: Conventional LASIK
arm group label: Wavefront-guided LASIK
other name: Device: Carl Zeiss Meditec Visumax femtosecond LASIK
other name: Device: Carl Zeiss Meditec MEL-80 excimer laser.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Anders Ivarsen, MD, PhD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Anders Ivarsen
investigator title: MD, PhD
mesh term: Myopia