<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/NCT01672814</url>
  </required_header>
  <id_info>
    <org_study_id>VED-001</org_study_id>
    <nct_id>NCT01672814</nct_id>
  </id_info>
  <brief_title>Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus</brief_title>
  <official_title>A Randomized, Controlled Study of the Vedera™ KXS Microwave System With Corneal Collagen Cross-Linking Compared With Corneal Collagen Cross-Linking Alone for Eyes With Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornea and Laser Eye Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cornea and Laser Eye Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure,&#xD;
      also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen&#xD;
      crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in&#xD;
      patients with keratoconus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to compare the safety and efficacy of the Vedera KXS (a&#xD;
      microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX&#xD;
      (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in&#xD;
      reducing corneal curvature in patients with keratoconus. Patients will be randomized into one&#xD;
      of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen&#xD;
      cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave&#xD;
      energy in an annular configuration. The goal of this procedure is to reshape the cornea to&#xD;
      flatten the cornea and improve corneal topography in patients with keratoconus. The primary&#xD;
      goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent&#xD;
      progression of the disease. Moreover, investigations of crosslinking have shown the procedure&#xD;
      not only to decrease keratoconus progression, but also to decrease the steepness of the cone&#xD;
      and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism&#xD;
      of improvement differs between the procedures, this study will compare the combined&#xD;
      microwave/crosslinking treatment to crosslinking alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Keratometry</measure>
    <time_frame>12 months</time_frame>
    <description>The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint,the change in maximum keratometry (Kmax)from baseline will be evaluated at 1,3 and 6 months for all eyes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manifest refraction</measure>
    <time_frame>12 months</time_frame>
    <description>The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3,and 6 months to look at the effect of wound healing on this variable.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1,3, and 6 months following the procedure will be analyzed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Endothelial cell density</measure>
    <time_frame>12 months</time_frame>
    <description>Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to KXS/CXL and CXL alone treatment and at 12 months postoperatively.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>Keraflex combined with Crosslinking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vedera KXS microwave system used in conjunction with corneal collagen crosslinking performed with VibeX (Riboflavin ophthalmic solution)and the KXL UV System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corneal collagen crosslinking alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Corneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>riboflavin ophthalmic solution</intervention_name>
    <description>Administration of riboflavin every 2 minutes for 20 minutes</description>
    <arm_group_label>Corneal collagen crosslinking alone</arm_group_label>
    <arm_group_label>Keraflex combined with Crosslinking</arm_group_label>
    <other_name>VibeX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vedera KXS Microwave System</intervention_name>
    <description>The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.</description>
    <arm_group_label>Keraflex combined with Crosslinking</arm_group_label>
    <other_name>Keraflex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Provide written consent and sign a HIPAA form&#xD;
&#xD;
          -  Willingness and ability to follow all instructions and comply with schedule for&#xD;
             follow-up visits&#xD;
&#xD;
          -  For females capable of becoming pregnant, agree to have urine pregnancy testing&#xD;
             performed prior to treatment; must not be lactating, and must agree to use a medically&#xD;
             acceptable form of birth control for at least one week prior to the treatment and&#xD;
             continue to use the method until 1 month after the last dose of investigational&#xD;
             product.&#xD;
&#xD;
          -  Having topographic evidence of keratoconus which is graded as moderate or severe&#xD;
             keratoconus&#xD;
&#xD;
          -  Presence of central or inferior steepening on the Pentacam map&#xD;
&#xD;
          -  Steepest keratometry (Kmax) value greater than or equal to 51.00D&#xD;
&#xD;
          -  BSCVA of 80 letters or fewer for keratoconus on ETDRS chart&#xD;
&#xD;
          -  Contact lens wearers only: remove contact lenses one week prior to the screening&#xD;
             refraction&#xD;
&#xD;
          -  Contact lens wearers only: manifest refraction must be stable between two visits that&#xD;
             occur at least 7 days apart.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications, sensitivity or known allergy to the use of the test articles(S) or&#xD;
             their components&#xD;
&#xD;
          -  If female, be pregnant, nursing, or planning a pregnancy or have a positive urine&#xD;
             pregnancy test at Visit 2 prior to treatment or during the course of the study&#xD;
&#xD;
          -  Eyes classified as either normal,atypical normal,keratoconus suspect or mild&#xD;
             keratoconus on the severity grading scheme&#xD;
&#xD;
          -  A history of the insertion of INTACS in the eye to be treated&#xD;
&#xD;
          -  A history of previous limbal relaxing incision procedure in the eye to be treated&#xD;
&#xD;
          -  Corneal pachymetry that is &lt;350 microns at the thinnest point measured by Pentacam in&#xD;
             the eye to be treated&#xD;
&#xD;
          -  Eyes which are aphakic&#xD;
&#xD;
          -  Eyes which are pseudophakic and do not have a UV blocking lens implanted&#xD;
&#xD;
          -  Previous ocular condition (other than refractive error) in the eye to be treated that&#xD;
             may predispose the eye for future complications.&#xD;
&#xD;
          -  A history of delayed epithelial healing in the eye to be treated&#xD;
&#xD;
          -  Patients with nystagmus or any other condition that would prevent a steady gaze during&#xD;
             the treatment or other diagnostic tests&#xD;
&#xD;
          -  Patients with a current condition that, in the investigator's opinion,would interfere&#xD;
             with or prolong epithelial healing&#xD;
&#xD;
          -  Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking&#xD;
             treatment&#xD;
&#xD;
          -  A history of previous corneal cross-linking treatment in the eye to be treated&#xD;
&#xD;
          -  Have used an investigational drug or device within 30 days of the study or be&#xD;
             concurrently enrolled in another investigational drug or device study within 30 days&#xD;
             of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter S Hersh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornea and Laser Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cornea and Laser Eye Institue - Hersh Vision Group</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Keratoconus</keyword>
  <keyword>Collagen Crosslinking</keyword>
  <keyword>Riboflavin</keyword>
  <keyword>Microwave</keyword>
  <keyword>Keraflex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</mesh_term>
    <mesh_term>Ophthalmic Solutions</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/NCT01672814
org study id: VED-001
nct id: NCT01672814
lead sponsor: 
has dmc: No
This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure,
      also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen
      crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in
      patients with keratoconus.
The objective of this study is to compare the safety and efficacy of the Vedera KXS (a
      microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX
      (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in
      reducing corneal curvature in patients with keratoconus. Patients will be randomized into one
      of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen
      cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave
      energy in an annular configuration. The goal of this procedure is to reshape the cornea to
      flatten the cornea and improve corneal topography in patients with keratoconus. The primary
      goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent
      progression of the disease. Moreover, investigations of crosslinking have shown the procedure
      not only to decrease keratoconus progression, but also to decrease the steepness of the cone
      and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism
      of improvement differs between the procedures, this study will compare the combined
      microwave/crosslinking treatment to crosslinking alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Keratometry
time frame: 12 months
description: The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint,the change in maximum keratometry (Kmax)from baseline will be evaluated at 1,3 and 6 months for all eyes.
measure: Manifest refraction
time frame: 12 months
description: The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3,and 6 months to look at the effect of wound healing on this variable.
measure: Visual Acuity
time frame: 12 months
description: Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1,3, and 6 months following the procedure will be analyzed.
measure: Endothelial cell density
time frame: 12 months
description: Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to KXS/CXL and CXL alone treatment and at 12 months postoperatively.
arm group label: Keraflex combined with Crosslinking
arm group type: Active Comparator
description: Vedera KXS microwave system used in conjunction with corneal collagen crosslinking performed with VibeX (Riboflavin ophthalmic solution)and the KXL UV System
arm group label: Corneal collagen crosslinking alone
arm group type: Active Comparator
description: Corneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system
intervention type: Drug
intervention name: riboflavin ophthalmic solution
description: Administration of riboflavin every 2 minutes for 20 minutes
arm group label: Corneal collagen crosslinking alone
arm group label: Keraflex combined with Crosslinking
other name: VibeX
intervention type: Device
intervention name: Vedera KXS Microwave System
description: The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.
arm group label: Keraflex combined with Crosslinking
other name: Keraflex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter S Hersh, MD
role: Principal Investigator
affiliation: Cornea and Laser Eye Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Riboflavin
mesh term: Ophthalmic Solutions