<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/NCT02189447</url>
  </required_header>
  <id_info>
    <org_study_id>TEC 126</org_study_id>
    <nct_id>NCT02189447</nct_id>
  </id_info>
  <brief_title>Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Eye Center and The Eye Foundation for Research in Ophthalmology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Eye Center and The Eye Foundation for Research in Ophthalmology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking&#xD;
      in patients with keratoconus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus</measure>
    <time_frame>6 months</time_frame>
    <description>The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>Refractive surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus</intervention_name>
    <description>Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting</description>
    <arm_group_label>Refractive surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  contact lens intolerance&#xD;
&#xD;
          -  corneal thickness &gt; 450 micrometers&#xD;
&#xD;
          -  Keratometry &lt; 56 diopters&#xD;
&#xD;
          -  Astigmatism &lt; 6 diopters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  corneal thickness &lt; 450 micrometers&#xD;
&#xD;
          -  Keratometry &gt; 56 diopters&#xD;
&#xD;
          -  Astigmatism &gt; 6 diopters&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Keratoconus</keyword>
  <keyword>Ectasia</keyword>
  <keyword>Corneal Cross-linking</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/NCT02189447
org study id: TEC 126
nct id: NCT02189447
lead sponsor: 
has dmc: No
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking
      in patients with keratoconus
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
time frame: 6 months
description: The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.
arm group label: Refractive surgery
arm group type: Experimental
description: Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.
intervention type: Procedure
intervention name: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
description: Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting
arm group label: Refractive surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Keratoconus