<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/NCT01726283</url>
  </required_header>
  <id_info>
    <org_study_id>CXL-RSR</org_study_id>
    <nct_id>NCT01726283</nct_id>
  </id_info>
  <brief_title>Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia</brief_title>
  <official_title>Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cxlusa</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cxlusa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced&#xD;
      cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and&#xD;
      biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that&#xD;
      are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that&#xD;
      will be undergoing laser vision correction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced&#xD;
      cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and&#xD;
      biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that&#xD;
      are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that&#xD;
      will be undergoing laser vision correction. CXL is thought to augment the tectonic strength&#xD;
      of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this&#xD;
      non-randomized study is to compare the visual results of patients who are suspicious for&#xD;
      having an increased risk of ectasia with laser vision correction compared to a group of&#xD;
      patients that does not have these risk factors. All excimer laser ophthalmic procedures&#xD;
      currently being performed to correct myopia, hyperopia or astigmatism with FDA approved&#xD;
      excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea&#xD;
      biomechanically. This can result in ectasia even in patients without pre-existing risk&#xD;
      factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Best-Corrected Visual Acuity</measure>
    <time_frame>Month 9</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Residual Refractive error at the 1, 3 and 6 month visits</measure>
    <time_frame>Months 1, 3, and 6</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Fruste Keratoconus</condition>
  <condition>Risk of Ectasia</condition>
  <arm_group>
    <arm_group_label>low risk subjects for developing post-operative ectasia</arm_group_label>
    <description>Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects at Risk for Ectasia</arm_group_label>
    <description>Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Corneal Cross-Linking</intervention_name>
    <description>Corneal cross-linking procedure conducted during vision correction surgery.</description>
    <arm_group_label>Subjects at Risk for Ectasia</arm_group_label>
    <arm_group_label>low risk subjects for developing post-operative ectasia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Riboflavin</intervention_name>
    <description>Riboflavin will be instilled prior to corneal cross linking.</description>
    <arm_group_label>Subjects at Risk for Ectasia</arm_group_label>
    <arm_group_label>low risk subjects for developing post-operative ectasia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Up to 4 potential risk factors for ectasia&#xD;
&#xD;
          -  A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste&#xD;
             pellucid marginal degeneration, asymmetric astigmatism, or increased posterior&#xD;
             float/posterior corneal surface shape.&#xD;
&#xD;
          -  B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or&#xD;
             Pentacam&#xD;
&#xD;
          -  C. Age 18 to 25&#xD;
&#xD;
          -  D. Planned Residual stromal bed between 250 and 300 microns&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  Likely to complete all study visits&#xD;
&#xD;
          -  Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye&#xD;
&#xD;
          -  Patients with and without previous laser vision correction are eligible for&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frank keratoconus, Pellucid, or Post-LASIK ectasia&#xD;
&#xD;
          -  Less than 20/30 BSCVA in either eye&#xD;
&#xD;
          -  Corneal scarring that markedly affects vision&#xD;
&#xD;
          -  Contraindications to any study medications or their components&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Active Herpes Corneal Disease&#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>William Trattler, MD</last_name>
    <role>Study Director</role>
    <affiliation>Center For Excellence In Eye Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roy Rubinfeld</last_name>
    <role>Study Director</role>
    <affiliation>CXL-USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schwartz Laser Eye Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clear View Eye &amp; Laser Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Excellence in Eye Care</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TLC Laser Eye Center</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Talamo Laser Eye Center</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Consultants</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Eye Clinic</name>
      <address>
        <city>Breckville</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TLC Laser Eye Center</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fruste keratoconus</keyword>
  <keyword>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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</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/NCT01726283
org study id: CXL-RSR
nct id: NCT01726283
lead sponsor: 
has dmc: No
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced
      cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and
      biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that
      are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that
      will be undergoing laser vision correction.
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced
      cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and
      biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that
      are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that
      will be undergoing laser vision correction. CXL is thought to augment the tectonic strength
      of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this
      non-randomized study is to compare the visual results of patients who are suspicious for
      having an increased risk of ectasia with laser vision correction compared to a group of
      patients that does not have these risk factors. All excimer laser ophthalmic procedures
      currently being performed to correct myopia, hyperopia or astigmatism with FDA approved
      excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea
      biomechanically. This can result in ectasia even in patients without pre-existing risk
      factors.
observational model: Case-Only
time perspective: Prospective
measure: Postoperative Best-Corrected Visual Acuity
time frame: Month 9
measure: Residual Refractive error at the 1, 3 and 6 month visits
time frame: Months 1, 3, and 6
arm group label: low risk subjects for developing post-operative ectasia
description: Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
arm group label: Subjects at Risk for Ectasia
description: Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
intervention type: Device
intervention name: Corneal Cross-Linking
description: Corneal cross-linking procedure conducted during vision correction surgery.
arm group label: Subjects at Risk for Ectasia
arm group label: low risk subjects for developing post-operative ectasia
intervention type: Drug
intervention name: Riboflavin
description: Riboflavin will be instilled prior to corneal cross linking.
arm group label: Subjects at Risk for Ectasia
arm group label: low risk subjects for developing post-operative ectasia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Trattler, MD
role: Study Director
affiliation: Center For Excellence In Eye Care
last name: Roy Rubinfeld
role: Study Director
affiliation: CXL-USA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Dilatation, Pathologic
mesh term: Riboflavin