<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/NCT01708538</url>
  </required_header>
  <id_info>
    <org_study_id>Rush CXL</org_study_id>
    <nct_id>NCT01708538</nct_id>
  </id_info>
  <brief_title>The Effects of Corneal Collagen Cross-linking</brief_title>
  <official_title>Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush Eye Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush Eye Associates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The corneal collagen cross-linking treatment has been used with increasing success to treat&#xD;
      corneal dystrophies such as &quot;keratoconus.&quot; Recent advances have allowed different techniques&#xD;
      for performing this cross-linking treatment. This study investigates the effects of corneal&#xD;
      cross-linking using different surgical techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>Best corrected Snellen acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Keratometry measurements</measure>
    <time_frame>1 year</time_frame>
    <description>Average curvature of the cornea</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Corneal Ectasia Disorders Including Keratoconus</condition>
  <arm_group>
    <arm_group_label>Epithelium on</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epi not removed during CXL treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epithelium off</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epi removed before CXL treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CXL</intervention_name>
    <description>corneal crosslinking</description>
    <arm_group_label>Epithelium off</arm_group_label>
    <arm_group_label>Epithelium on</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 10-70, willing to participate, diagnosis of corneal ectasia disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to participate in trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sloan W Rush, MD</last_name>
    <phone>806-353-0125</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Rush Eye Associates</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunday Fowler</last_name>
      <phone>806-353-0125</phone>
    </contact>
    <investigator>
      <last_name>Sloan W Rush, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 20, 2023</submitted>
    <returned>February 14, 2023</returned>
    <submitted>April 4, 2023</submitted>
    <returned>April 25, 2023</returned>
  </pending_results>
  <!-- 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/NCT01708538
org study id: Rush CXL
nct id: NCT01708538
lead sponsor: 
has dmc: Yes
The corneal collagen cross-linking treatment has been used with increasing success to treat
      corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques
      for performing this cross-linking treatment. This study investigates the effects of corneal
      cross-linking using different surgical techniques.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual acuity
time frame: 1 year
description: Best corrected Snellen acuity
measure: Keratometry measurements
time frame: 1 year
description: Average curvature of the cornea
arm group label: Epithelium on
arm group type: Active Comparator
description: Epi not removed during CXL treatment
arm group label: Epithelium off
arm group type: Active Comparator
description: Epi removed before CXL treatment
intervention type: Drug
intervention name: CXL
description: corneal crosslinking
arm group label: Epithelium off
arm group label: Epithelium on
criteria: 
gender: All
minimum age: 10 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sloan W Rush, MD
phone: 806-353-0125
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Dilatation, Pathologic
submitted: January 20, 2023
returned: February 14, 2023
submitted: April 4, 2023
returned: April 25, 2023