<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/NCT01711190</url>
  </required_header>
  <id_info>
    <org_study_id>S53708</org_study_id>
    <nct_id>NCT01711190</nct_id>
  </id_info>
  <brief_title>Astigmatism Post-trabeculectomy</brief_title>
  <official_title>The Effect of Trabeculectomy on Astigmatism.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project:&#xD;
&#xD;
        1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and&#xD;
           intracameral administration of bevacizumab.&#xD;
&#xD;
        2. Medium-term follow up (6 months) of the induced corneal astigmatism.&#xD;
&#xD;
        3. Investigating correlations between postoperative astigmatism, particularly with the&#xD;
           postoperative IOP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ocular cylinder and axis untill 6 months after trabeculectomy.</measure>
    <time_frame>pre-operative until 6 months post-operative</time_frame>
    <description>Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses.</description>
  </primary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Glaucoma</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>trabeculectomy</intervention_name>
    <description>Filtering surgery to reduce the intra-ocular pressure.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients having a primary trabeculectomy between January and April 2012 for glaucoma&#xD;
        that was not adequately controlled with maximal tolerated medical therapy and/or laser&#xD;
        therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary open angle glaucoma&#xD;
&#xD;
          -  Normal tension glaucoma&#xD;
&#xD;
          -  Pseudoexfoliation glaucoma&#xD;
&#xD;
          -  Pigment dispersion glaucoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to sign the informed consent.&#xD;
&#xD;
          -  Patients with primary angle closure glaucoma (PACG).&#xD;
&#xD;
          -  Patients younger than 18 years old.&#xD;
&#xD;
          -  Other ocular diseases besides glaucoma.&#xD;
&#xD;
          -  Significant corneal opacities.&#xD;
&#xD;
          -  Refractive error more than + or -6.00 diopters.&#xD;
&#xD;
          -  Visual acuity less than 0.05&#xD;
&#xD;
          -  Previous intra-ocular surgery (except cataract surgery more than six months preceding&#xD;
             the trabeculectomy).&#xD;
&#xD;
          -  Laser treatment for glaucoma within 6 months of the surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heleen Delbeke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sint-Raphaël hospital</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>February 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>June 22, 2013</last_update_submitted>
  <last_update_submitted_qc>June 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Heleen Delbeke</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>trabeculectomy</keyword>
  <keyword>astigmatism</keyword>
  <keyword>intraocular pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT01711190
org study id: S53708
nct id: NCT01711190
lead sponsor: 
has dmc: No
The aim of this project:

        1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and
           intracameral administration of bevacizumab.

        2. Medium-term follow up (6 months) of the induced corneal astigmatism.

        3. Investigating correlations between postoperative astigmatism, particularly with the
           postoperative IOP.
observational model: Cohort
time perspective: Prospective
measure: Change in ocular cylinder and axis untill 6 months after trabeculectomy.
time frame: pre-operative until 6 months post-operative
description: Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses.
intervention type: Procedure
intervention name: trabeculectomy
description: Filtering surgery to reduce the intra-ocular pressure.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heleen Delbeke, MD
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Heleen Delbeke
investigator title: MD
mesh term: Glaucoma
mesh term: Astigmatism