<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/NCT04475900</url>
  </required_header>
  <id_info>
    <org_study_id>BO-EK-195052020</org_study_id>
    <nct_id>NCT04475900</nct_id>
  </id_info>
  <brief_title>Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics</brief_title>
  <acronym>EyeTwin</acronym>
  <official_title>Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics - Selection and Evaluation of Eligible Patients With Certain Ocular Diseases Associated With Biomechanical Alterations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fraunhofer Institute for Ceramic Technologies and Systems IKTS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the investigation of biomechanical properties of the cornea&#xD;
      using computer-aided data analysis. Currently, it is known that keratoconus and glaucoma are&#xD;
      ocular disease that are associated with biomechanical alterations of the cornea. Corneal&#xD;
      ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of&#xD;
      visual acuity while the cornea becomes steeper, thinner and irregular. For these patients,&#xD;
      surgical intervention (e.g. corneal cross-linking) is performed, in case of disease&#xD;
      progression. In glaucoma, the information about corneal alterations serves in two ways,&#xD;
      first, correct measurement of intra ocular pressure (IOP); second, early diagnosis of&#xD;
      suspects before visual field defects are detectable.&#xD;
&#xD;
      Especially, the Corvis ST is an air-puff tonometer that measures intraocular pressure,&#xD;
      corneal thickness (CCT) as well as dynamic corneal response (DCR) parameters. Most of the DCR&#xD;
      parameters are affected by IOP and CCT: Therefore, algorithm are needed to determine&#xD;
      parameters without impact of IOP and CCT that are describe the biomechanical properties of&#xD;
      the cornea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, an eye twin based on finite element modeling is used to measure advanced&#xD;
      properties of corneal biomechanics. Raw data of Corvis ST measurement are exported from the&#xD;
      device and imported into the model. The outcome of these calculations are merged together and&#xD;
      are compared to further clinical findings (e. g. corneal topography and tomography, axial eye&#xD;
      length).&#xD;
&#xD;
      Further information were obtained:&#xD;
&#xD;
      Age, sex, refraction, family history, known duration of disease, previous ocular surgery,&#xD;
      systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence&#xD;
      tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular&#xD;
      Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical&#xD;
      biometry, confocal microscopy, endothelium cell count.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>New biomechanical parameters of the cornea</measure>
    <time_frame>2 years</time_frame>
    <description>To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dependence of new biomechanical Parameters of the cornea from influencing factors</measure>
    <time_frame>1 year</time_frame>
    <description>e. g. corneal thickness, intraocular pressure</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">372</enrollment>
  <condition>Corneal Ectasia</condition>
  <condition>Corneal Disease</condition>
  <condition>Corneal Astigmatism</condition>
  <condition>Keratoconus</condition>
  <condition>Glaucoma</condition>
  <condition>Open Angle Glaucoma</condition>
  <condition>Normal Tension Glaucoma</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Healthy eyes without any signs of ocular diseases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ectasia</arm_group_label>
    <description>ectasia suspects early, moderate and advanced keratoconus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma</arm_group_label>
    <description>Normal Tension glaucoma Primary Open-Angle Glaucoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)</intervention_name>
    <description>To measure corneal biomechanics with Scheimpflug based tonometry</description>
    <arm_group_label>Ectasia</arm_group_label>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)</intervention_name>
    <description>To measure corneal topography and tomography with Scheimpflug tomograph</description>
    <arm_group_label>Ectasia</arm_group_label>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Optic nerve head measurement</intervention_name>
    <description>To measure optic nerve excavation</description>
    <arm_group_label>Glaucoma</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease&#xD;
        groups concerning age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  corneal ectasia (keratoconus) or ectasia suspect&#xD;
&#xD;
          -  glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cornea</keyword>
  <keyword>Ectasia</keyword>
  <keyword>Keratoconus</keyword>
  <keyword>Finite Element Modelling</keyword>
  <keyword>computer-aided data analysis</keyword>
  <keyword>Glaucoma</keyword>
  <keyword>Corneal biomechanics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Keratoconus</mesh_term>
    <mesh_term>Astigmatism</mesh_term>
    <mesh_term>Low Tension Glaucoma</mesh_term>
    <mesh_term>Corneal Diseases</mesh_term>
    <mesh_term>Dilatation, Pathologic</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/NCT04475900
org study id: BO-EK-195052020
nct id: NCT04475900
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is the investigation of biomechanical properties of the cornea
      using computer-aided data analysis. Currently, it is known that keratoconus and glaucoma are
      ocular disease that are associated with biomechanical alterations of the cornea. Corneal
      ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of
      visual acuity while the cornea becomes steeper, thinner and irregular. For these patients,
      surgical intervention (e.g. corneal cross-linking) is performed, in case of disease
      progression. In glaucoma, the information about corneal alterations serves in two ways,
      first, correct measurement of intra ocular pressure (IOP); second, early diagnosis of
      suspects before visual field defects are detectable.

      Especially, the Corvis ST is an air-puff tonometer that measures intraocular pressure,
      corneal thickness (CCT) as well as dynamic corneal response (DCR) parameters. Most of the DCR
      parameters are affected by IOP and CCT: Therefore, algorithm are needed to determine
      parameters without impact of IOP and CCT that are describe the biomechanical properties of
      the cornea.
In this study, an eye twin based on finite element modeling is used to measure advanced
      properties of corneal biomechanics. Raw data of Corvis ST measurement are exported from the
      device and imported into the model. The outcome of these calculations are merged together and
      are compared to further clinical findings (e. g. corneal topography and tomography, axial eye
      length).

      Further information were obtained:

      Age, sex, refraction, family history, known duration of disease, previous ocular surgery,
      systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence
      tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular
      Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical
      biometry, confocal microscopy, endothelium cell count.
observational model: Case-Control
time perspective: Prospective
measure: New biomechanical parameters of the cornea
time frame: 2 years
description: To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings
measure: Dependence of new biomechanical Parameters of the cornea from influencing factors
time frame: 1 year
description: e. g. corneal thickness, intraocular pressure
arm group label: Healthy
description: Healthy eyes without any signs of ocular diseases
arm group label: Ectasia
description: ectasia suspects early, moderate and advanced keratoconus
arm group label: Glaucoma
description: Normal Tension glaucoma Primary Open-Angle Glaucoma
intervention type: Diagnostic Test
intervention name: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)
description: To measure corneal biomechanics with Scheimpflug based tonometry
arm group label: Ectasia
arm group label: Glaucoma
arm group label: Healthy
intervention type: Diagnostic Test
intervention name: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)
description: To measure corneal topography and tomography with Scheimpflug tomograph
arm group label: Ectasia
arm group label: Glaucoma
arm group label: Healthy
intervention type: Diagnostic Test
intervention name: Optic nerve head measurement
description: To measure optic nerve excavation
arm group label: Glaucoma
arm group label: Healthy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Keratoconus
mesh term: Astigmatism
mesh term: Low Tension Glaucoma
mesh term: Corneal Diseases
mesh term: Dilatation, Pathologic