<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/NCT03030755</url>
  </required_header>
  <id_info>
    <org_study_id>13-213</org_study_id>
    <nct_id>NCT03030755</nct_id>
  </id_info>
  <brief_title>Corneal Elastography and Patient Specific Modeling</brief_title>
  <official_title>Corneal Elastography and Patient Specific Modeling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to develop measurement tools and simulation technology for&#xD;
      characterizing and predicting individual responses to corneal treatments and for advancing&#xD;
      understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and&#xD;
      are being evaluated for corneal crosslinking or 2) have refractive error and are being&#xD;
      evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to&#xD;
      assess their mechanical properties and will have computational simulations performed to&#xD;
      predict the response to treatment. One aim of the study is to test the hypothesis that&#xD;
      computational models can predict the cornea's shape changes within clinically acceptable&#xD;
      limits of error.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanical condition of the cornea is an important but elusive property of the eye to&#xD;
      characterize. Weakness in the cornea is thought to be one of the primary causes of corneal&#xD;
      ectasia, a major cause of visual impairment worldwide. Corneal weakness is also important to&#xD;
      identify in refractive surgery candidates since such surgeries often involve tissue removal&#xD;
      that could lead to corneal instability in certain predisposed patients.&#xD;
&#xD;
      In this study, subjects will undergo imaging with an optical coherence tomography (OCT)-based&#xD;
      system to characterize corneal biomechanical properties. In addition, computational&#xD;
      representations of the eye will be built from images and interventions will be simulated and&#xD;
      compared to actual treatment outcomes. No investigational procedures or study-specific&#xD;
      interventions other than imaging are involved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive accuracy of computational models in corneal surgery</measure>
    <time_frame>3 month</time_frame>
    <description>Computational model predictions of corneal interventions will be compared to actual clinical outcomes for each enrolled subject</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cornea; Ectasia</condition>
  <condition>Refractive Errors</condition>
  <condition>Keratoconus</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optical coherence tomography</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with refractive error who present for screening for refractive surgery and&#xD;
        individuals with keratoconus who are evaluatedat the Cole Eye Institute in Cleveland, Ohio&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient with keratoconus diagnosed by standard criteria, including topographic&#xD;
             steepness, irregular astigmatism with a pattern consistent with keratoconus.&#xD;
&#xD;
          -  Any patient deemed a candidate for LASIK (laser vision correction) and scheduled for&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent, including non-English speaking (if interpreter&#xD;
             not available) and cognitively/mentally impaired (if legal guardian not available).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Dupps, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pamela Hoffman, MS</last_name>
    <phone>216-445-5248</phone>
    <email>moorehp@ccf.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Rusnak</last_name>
    <phone>216-445-1256</phone>
    <email>rusnakr@ccf.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation Cole Eye Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Hoffman, MS</last_name>
      <phone>216-445-5248</phone>
      <email>moorehp@ccf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ford MR, Dupps WJ Jr, Rollins AM, Sinha RA, Hu Z. Method for optical coherence elastography of the cornea. J Biomed Opt. 2011 Jan-Feb;16(1):016005. doi: 10.1117/1.3526701.</citation>
    <PMID>21280911</PMID>
  </reference>
  <reference>
    <citation>Sinha Roy A, Dupps WJ Jr. Patient-specific computational modeling of keratoconus progression and differential responses to collagen cross-linking. Invest Ophthalmol Vis Sci. 2011 Nov 25;52(12):9174-87. doi: 10.1167/iovs.11-7395.</citation>
    <PMID>22039252</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>William Dupps Jr., MD</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030755
org study id: 13-213
nct id: NCT03030755
lead sponsor: 
has dmc: No
The goal of this research is to develop measurement tools and simulation technology for
      characterizing and predicting individual responses to corneal treatments and for advancing
      understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and
      are being evaluated for corneal crosslinking or 2) have refractive error and are being
      evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to
      assess their mechanical properties and will have computational simulations performed to
      predict the response to treatment. One aim of the study is to test the hypothesis that
      computational models can predict the cornea's shape changes within clinically acceptable
      limits of error.
The mechanical condition of the cornea is an important but elusive property of the eye to
      characterize. Weakness in the cornea is thought to be one of the primary causes of corneal
      ectasia, a major cause of visual impairment worldwide. Corneal weakness is also important to
      identify in refractive surgery candidates since such surgeries often involve tissue removal
      that could lead to corneal instability in certain predisposed patients.

      In this study, subjects will undergo imaging with an optical coherence tomography (OCT)-based
      system to characterize corneal biomechanical properties. In addition, computational
      representations of the eye will be built from images and interventions will be simulated and
      compared to actual treatment outcomes. No investigational procedures or study-specific
      interventions other than imaging are involved.
observational model: Cohort
time perspective: Prospective
measure: Predictive accuracy of computational models in corneal surgery
time frame: 3 month
description: Computational model predictions of corneal interventions will be compared to actual clinical outcomes for each enrolled subject
intervention type: Other
intervention name: Optical coherence tomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Dupps, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Pamela Hoffman, MS
phone: 216-445-5248
email: moorehp@ccf.org
last name: Rachel Rusnak
phone: 216-445-1256
email: rusnakr@ccf.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Ford MR, Dupps WJ Jr, Rollins AM, Sinha RA, Hu Z. Method for optical coherence elastography of the cornea. J Biomed Opt. 2011 Jan-Feb;16(1):016005. doi: 10.1117/1.3526701.
PMID: 21280911
citation: Sinha Roy A, Dupps WJ Jr. Patient-specific computational modeling of keratoconus progression and differential responses to collagen cross-linking. Invest Ophthalmol Vis Sci. 2011 Nov 25;52(12):9174-87. doi: 10.1167/iovs.11-7395.
PMID: 22039252
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: William Dupps Jr., MD
investigator title: Staff Physician
mesh term: Keratoconus
mesh term: Refractive Errors
sharing ipd: No