<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/NCT03760432</url>
  </required_header>
  <id_info>
    <org_study_id>6612-CXL</org_study_id>
    <secondary_id>R01EY028755</secondary_id>
    <nct_id>NCT03760432</nct_id>
  </id_info>
  <brief_title>Collagen Cross-linking in Keratoconus</brief_title>
  <official_title>Clinical Trial of Laser Custom Corneal Collagen Cross-Linking in Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the&#xD;
      depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in&#xD;
      patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly&#xD;
      decreases corneal aberrations and improves vision. This study will use OCT-guided setting for&#xD;
      the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess&#xD;
      the affect on visual outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the U.S., CXL and topography-guided laser ablation were approved independently, but not&#xD;
      together. Another variation in technique involves the use of mitomycin-C (MMC), which is&#xD;
      effective in reducing corneal haze after the laser surface ablation. Use of MMC during the&#xD;
      laser custom CXL was associated with better outcomes, but in separate trials that could not&#xD;
      be directly compared. This study will use OCT measurements to evaluate the magnitudes of&#xD;
      direct and indirect laser actions after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Improvement in best spectacle-corrected visual acuity after laser custom CXL</measure>
    <time_frame>6 months after the CXL procedure</time_frame>
    <description>The primary goal of the trial is to determine the extent of visual improvement after laser custom CXL compared to preoperative measurements. Vision will be checked at various time points, but the primary time point will be 6-months post-procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine CXL demarcation line depth</measure>
    <time_frame>1 month after the CXL procedure</time_frame>
    <description>The study will use OCT imaging to measure the CXL demarcation line inside the entire optical zone. The demarcation line indicates the portion of corneal stroma being cross-linked. This helps determine to what extent the cornea is being strengthened.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCT-guided custom laser CXL</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Custom Corneal Collagen Cross-Linking</intervention_name>
    <description>Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for smoothing the anterior corneal surface and removing any present opacities. The surgeon uses the OCT data to plan treatment parameters while preserving at least 360 microns of residual corneal stroma using a phototherapeutic keratectomy procedure. After the laser procedure, adjunctive MMC or saline solution will be applied to the cornea in accordance with the group to which the treated eye is randomized. The CXL procedure is then performed following the FDA-approved CXL regimen by Avedro, Inc.</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of keratoconus&#xD;
&#xD;
          -  Minimum corneal thickness of 410 microns&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to maintain fixation for OCT imaging&#xD;
&#xD;
          -  Inability to commit to required study visits&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may&#xD;
             limit the visual outcome after surgery&#xD;
&#xD;
          -  Mature cataracts if found to limit visual potential to worse than 20/40&#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>David Huang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denzil Romfh, OD</last_name>
    <phone>503-494-4351</phone>
    <email>romfhd@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Humberto Martinez, COT</last_name>
    <phone>503-494-7712</phone>
    <email>martinhu@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denzil Romfh, OD</last_name>
      <phone>503-494-4351</phone>
      <email>romfhd@ohsu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Humberto Martinez, COT</last_name>
      <phone>503-494-7712</phone>
      <email>martinhu@ohsu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>David Huang</investigator_full_name>
    <investigator_title>Peterson Professor of Ophthalmology &amp; Professor of Biomedical Engineering</investigator_title>
  </responsible_party>
  <keyword>Keratoconus (KCN)</keyword>
  <keyword>Optical Coherence Tomography (OCT)</keyword>
  <keyword>Collagen Cross-linking (CXL)</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/NCT03760432
org study id: 6612-CXL
secondary id: R01EY028755
nct id: NCT03760432
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Optical Coherence Tomography (OCT) devices are non-contact instruments that can measure the
      depth of scars, other causes of cloudiness of the cornea, and degree of corneal thinning in
      patients with keratoconus. Laser Custom Corneal Collagen Cross-linking (CXL) significantly
      decreases corneal aberrations and improves vision. This study will use OCT-guided setting for
      the lasers used in the corneal smoothing portion of the laser custom CXL procedure to assess
      the affect on visual outcomes.
In the U.S., CXL and topography-guided laser ablation were approved independently, but not
      together. Another variation in technique involves the use of mitomycin-C (MMC), which is
      effective in reducing corneal haze after the laser surface ablation. Use of MMC during the
      laser custom CXL was associated with better outcomes, but in separate trials that could not
      be directly compared. This study will use OCT measurements to evaluate the magnitudes of
      direct and indirect laser actions after the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in best spectacle-corrected visual acuity after laser custom CXL
time frame: 6 months after the CXL procedure
description: The primary goal of the trial is to determine the extent of visual improvement after laser custom CXL compared to preoperative measurements. Vision will be checked at various time points, but the primary time point will be 6-months post-procedure.
measure: Determine CXL demarcation line depth
time frame: 1 month after the CXL procedure
description: The study will use OCT imaging to measure the CXL demarcation line inside the entire optical zone. The demarcation line indicates the portion of corneal stroma being cross-linked. This helps determine to what extent the cornea is being strengthened.
arm group label: Surgery
arm group type: Experimental
description: OCT-guided custom laser CXL
intervention type: Procedure
intervention name: Laser Custom Corneal Collagen Cross-Linking
description: Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for smoothing the anterior corneal surface and removing any present opacities. The surgeon uses the OCT data to plan treatment parameters while preserving at least 360 microns of residual corneal stroma using a phototherapeutic keratectomy procedure. After the laser procedure, adjunctive MMC or saline solution will be applied to the cornea in accordance with the group to which the treated eye is randomized. The CXL procedure is then performed following the FDA-approved CXL regimen by Avedro, Inc.
arm group label: Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Huang, MD, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Denzil Romfh, OD
phone: 503-494-4351
email: romfhd@ohsu.edu
last name: Humberto Martinez, COT
phone: 503-494-7712
email: martinhu@ohsu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: David Huang
investigator title: Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
mesh term: Keratoconus