<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/NCT01682421</url>
  </required_header>
  <id_info>
    <org_study_id>AUH_DSAEK_STEROID</org_study_id>
    <nct_id>NCT01682421</nct_id>
  </id_info>
  <brief_title>Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation</brief_title>
  <official_title>Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation</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>
      After corneal transplantation, topical corticosteroids are used to reduce the risk of&#xD;
      rejection.&#xD;
&#xD;
      However, the optimal postoperative treatment regimen is unknown. In most cases, a topical&#xD;
      steroid is administered for at least 6 months after surgery, but it remains to be determined&#xD;
      whether potent steroids offer better protection than weak steroids. Also, the length of the&#xD;
      treatment is debated.&#xD;
&#xD;
      Since the use of steroids is not without potential serious ocular side effects, it is of&#xD;
      considerable importance to investigate these problems.&#xD;
&#xD;
      The study aims to examine the frequency of rejection episodes after posterior lamellar&#xD;
      keratoplasty; specifically comparing a short course of potent steroids versus a long course&#xD;
      of weak steroids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Actual">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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from rejection</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Endothelial Dystrophy</condition>
  <condition>Secondary Bullous Keratopathy</condition>
  <condition>Posterior Lamellar Keratoplasty</condition>
  <condition>Descemet's Stripping Endothelial Keratoplasty</condition>
  <arm_group>
    <arm_group_label>Weak steroid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Potent steroid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Weak steroid (Flurolon, Allergan)</intervention_name>
    <arm_group_label>Weak steroid</arm_group_label>
    <other_name>Flurolon, Allergan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potent steroid (Maxidex, Alcon)</intervention_name>
    <arm_group_label>Potent steroid</arm_group_label>
    <other_name>Maxidex, Alcon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated for primary or secondary corneal endothelial failure at the&#xD;
             department of ophthalmology, Aarhus University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fulfilling the above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ophthalmology, Aarhus Universtity 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_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/NCT01682421
org study id: AUH_DSAEK_STEROID
nct id: NCT01682421
lead sponsor: 
has dmc: No
After corneal transplantation, topical corticosteroids are used to reduce the risk of
      rejection.

      However, the optimal postoperative treatment regimen is unknown. In most cases, a topical
      steroid is administered for at least 6 months after surgery, but it remains to be determined
      whether potent steroids offer better protection than weak steroids. Also, the length of the
      treatment is debated.

      Since the use of steroids is not without potential serious ocular side effects, it is of
      considerable importance to investigate these problems.

      The study aims to examine the frequency of rejection episodes after posterior lamellar
      keratoplasty; specifically comparing a short course of potent steroids versus a long course
      of weak steroids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from rejection
time frame: 2 years
arm group label: Weak steroid
arm group type: Experimental
description: Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years.
arm group label: Potent steroid
arm group type: Experimental
description: Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment.
intervention type: Drug
intervention name: Weak steroid (Flurolon, Allergan)
arm group label: Weak steroid
other name: Flurolon, Allergan
intervention type: Drug
intervention name: Potent steroid (Maxidex, Alcon)
arm group label: Potent steroid
other name: Maxidex, Alcon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101