<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/NCT01682993</url>
  </required_header>
  <id_info>
    <org_study_id>367/2009</org_study_id>
    <nct_id>NCT01682993</nct_id>
  </id_info>
  <brief_title>Corneal Cross Linking and Topography Guided Excimer Laser Treatment</brief_title>
  <official_title>Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Topography guided laser treatment enables the surgeon to correct higher order aberrations in&#xD;
      corneas with irregular astigmatism. Several case reports and small uncontrolled trials have&#xD;
      been published on the combination of this treatment with corneal cross linking (CCL) in&#xD;
      patients with ectatic corneal diseases.&#xD;
&#xD;
      This randomized study will evaluate the safety and efficacy of a combined treatment of&#xD;
      corneal cross linking with a partial topography guided excimer laser treatment in eyes with&#xD;
      progressive ectatic corneal diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety (Pachymetry, K-readings)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>uncorrected visual acuity (UVCA)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>best corrected visual acuity (BCVA)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression of ectatic disease (by use of maximum keratometry readings = Kmax)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Keratoconus</condition>
  <condition>Pellucid Marginal Degeneration</condition>
  <arm_group>
    <arm_group_label>Corneal Cross Linking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a standard corneal cross linking treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corneal Cross Linking and Topo Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Topography guided Excimer Laser treatment and Corneal Cross Linking</intervention_name>
    <description>A topography guided excimer laser treatment will be performed prior to CCL in one session.</description>
    <arm_group_label>Corneal Cross Linking and Topo Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Corneal Cross Linking</intervention_name>
    <description>A standard corneal cross linking procedure will be performed in this arm.</description>
    <arm_group_label>Corneal Cross Linking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Patient age 18 - 40 years&#xD;
&#xD;
          -  Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to one of the used substances&#xD;
&#xD;
          -  Tendency towards excessive scar formation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Rheumatic diseases&#xD;
&#xD;
          -  Central corneal thickness below 450 µm&#xD;
&#xD;
          -  Active infection of the study eye&#xD;
&#xD;
          -  Previous corneal surgery of the study eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna, Department of Ophthalmology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 5, 2011</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Gerald Schmidinger</investigator_full_name>
    <investigator_title>MD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>corneal cross linking</keyword>
  <keyword>topography guided excimer laser</keyword>
  <keyword>Keratoconus</keyword>
  <keyword>Pellucid marginal degeneration</keyword>
  <keyword>Post Excimer ectasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</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/NCT01682993
org study id: 367/2009
nct id: NCT01682993
lead sponsor: 
has dmc: No
Topography guided laser treatment enables the surgeon to correct higher order aberrations in
      corneas with irregular astigmatism. Several case reports and small uncontrolled trials have
      been published on the combination of this treatment with corneal cross linking (CCL) in
      patients with ectatic corneal diseases.

      This randomized study will evaluate the safety and efficacy of a combined treatment of
      corneal cross linking with a partial topography guided excimer laser treatment in eyes with
      progressive ectatic corneal diseases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety (Pachymetry, K-readings)
time frame: 1 year
measure: uncorrected visual acuity (UVCA)
time frame: 1 year
measure: best corrected visual acuity (BCVA)
time frame: 1 year
measure: Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
time frame: 1 year
arm group label: Corneal Cross Linking
arm group type: Active Comparator
description: Patients will receive a standard corneal cross linking treatment
arm group label: Corneal Cross Linking and Topo Laser
arm group type: Experimental
description: Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.
intervention type: Other
intervention name: Topography guided Excimer Laser treatment and Corneal Cross Linking
description: A topography guided excimer laser treatment will be performed prior to CCL in one session.
arm group label: Corneal Cross Linking and Topo Laser
intervention type: Other
intervention name: Corneal Cross Linking
description: A standard corneal cross linking procedure will be performed in this arm.
arm group label: Corneal Cross Linking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gerald Schmidinger
investigator title: MD, Assistant Professor
mesh term: Keratoconus