<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/NCT01680354</url>
  </required_header>
  <id_info>
    <org_study_id>AUH_ASTIGMATISM</org_study_id>
    <nct_id>NCT01680354</nct_id>
  </id_info>
  <brief_title>Surgical Correction of Astigmatism</brief_title>
  <official_title>Comparative Study of Surgical Laser Correction of Astigmatism</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 correction for myopia and astigmatism using an excimer laser has been performed with&#xD;
      success for several years.&#xD;
&#xD;
      During the last 2 years, a new method for correction of refractive errors has emerged. In the&#xD;
      method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is&#xD;
      subsequently removed. For simple myopia this method has proved effective and on par with&#xD;
      excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the&#xD;
      treatment of astigmatism.&#xD;
&#xD;
      In the study, patients with high astigmatism are treated with conventional LASIK for&#xD;
      astigmatism in one eye and with ReLEx for astigmatism 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Withdrawn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>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2012</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>Visual acuity</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refraction</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>ReLEx</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One eye is treated with ReLEx the other with LASIK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LASIK</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One eye is treated with ReLEx the other with LASIK</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ReLEx</intervention_name>
    <arm_group_label>ReLEx</arm_group_label>
    <other_name>Device: Carl Zeiss Meditec Visumax Femtosecond Laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LASIK</intervention_name>
    <arm_group_label>LASIK</arm_group_label>
    <other_name>Device: Carl Zeiss Meditec MEL-80 excimer laser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Myopic astigmatism between -2.0 and -5.0 diopters&#xD;
&#xD;
          -  Maximal difference in spherical equivalent refraction of 2 D between eyes&#xD;
&#xD;
          -  No ocular or systemic disease&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
          -  Minimum BSCVA of 0.8 (decimal)&#xD;
&#xD;
          -  Normal corneal topography&#xD;
&#xD;
          -  Sufficient corneal thickness to allow the treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects not fulfilling the above criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 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>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/NCT01680354
org study id: AUH_ASTIGMATISM
nct id: NCT01680354
lead sponsor: 
has dmc: No
Laser correction for myopia and astigmatism using an excimer laser has been performed with
      success for several years.

      During the last 2 years, a new method for correction of refractive errors has emerged. In the
      method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is
      subsequently removed. For simple myopia this method has proved effective and on par with
      excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the
      treatment of astigmatism.

      In the study, patients with high astigmatism are treated with conventional LASIK for
      astigmatism in one eye and with ReLEx for astigmatism in the other.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity
time frame: 1 year
measure: Refraction
time frame: 1 year
arm group label: ReLEx
arm group type: Active Comparator
description: One eye is treated with ReLEx the other with LASIK
arm group label: LASIK
arm group type: Active Comparator
description: One eye is treated with ReLEx the other with LASIK
intervention type: Procedure
intervention name: ReLEx
arm group label: ReLEx
other name: Device: Carl Zeiss Meditec Visumax Femtosecond Laser
intervention type: Procedure
intervention name: LASIK
arm group label: 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
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Anders Ivarsen
investigator title: MD, PhD
mesh term: Astigmatism