xml: <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/NCT05973617</url>
    </required_header>
    <id_info>
      <org_study_id>005-2021-SN</org_study_id>
      <nct_id>NCT05973617</nct_id>
    </id_info>
    <brief_title>Development of an IT Tool Able to Identify Ocular Conditions</brief_title>
    <official_title>A Prospective Observational Study to Investigate the Role of the Biomechanics of the Cornea in Identifying Glaucoma or Anterior Eye Diseases and Create an IT Tool Able to Distinguish Between Them</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aston University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sandwell &amp; West Birmingham Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Aston 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>
        The aim of the study is to use machine learning to develop an IT tool able to differentiate&#xD;
        between eye conditions analysing corneal biomechanical data.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data will be collected using two different commercially available devices that are able to&#xD;
        measure corneal biomechanics. Corneal biomechanics will be measured in participants with&#xD;
        different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls&#xD;
        as it is well established that the above-mentioned conditions cause changes in corneal&#xD;
        biomechanical properties.&#xD;
  &#xD;
        Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and&#xD;
        it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal&#xD;
        Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to&#xD;
        temporally flatten the cornea and derive the properties of the tissue.&#xD;
  &#xD;
        Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre&#xD;
        (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine&#xD;
        clinical appointment. Healthy controls will be recruited at Aston University. This study&#xD;
        requires only one visit and there is no need of follow up.&#xD;
  &#xD;
        A portion of the data collected will be used to train machine learning algorithms to&#xD;
        differentiate between conditions, the remaining data will be used to test the accuracy of&#xD;
        newly created algorithms. The algorithm will be developed using Orange Data Mining.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Withdrawn</overall_status>
    <why_stopped>
      Study did not commence&#xD;
    </why_stopped>
    <start_date type="Anticipated">December 2022</start_date>
    <completion_date type="Anticipated">June 2023</completion_date>
    <primary_completion_date type="Anticipated">June 2023</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>First applanation velocity</measure>
      <time_frame>Day 1</time_frame>
      <description>Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First applanation time</measure>
      <time_frame>Day 1</time_frame>
      <description>Time frame of the first applanation of the cornea, measured using Corivs ST [s]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First applanation lenght</measure>
      <time_frame>Day 1</time_frame>
      <description>Lenght of the first applanation of the cornea, measured using Corivs ST [mm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Second applanation velocity</measure>
      <time_frame>Day 1</time_frame>
      <description>Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Second applanation time</measure>
      <time_frame>Day 1</time_frame>
      <description>Time frame of the second applanation of the cornea, measured using Corivs ST [s]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Second applanation lenght</measure>
      <time_frame>Day 1</time_frame>
      <description>Lenght of the second applanation of the cornea, measured using Corivs ST [mm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Highest concavity time</measure>
      <time_frame>Day 1</time_frame>
      <description>Time frame at highest concavity, measured using Corivs ST [s]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Highest concavity peak distance</measure>
      <time_frame>Day 1</time_frame>
      <description>Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Highest concavity radius</measure>
      <time_frame>Day 1</time_frame>
      <description>Radius of curvature at highest concavity, measured using Corivs ST [mm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Highest concavity deformation amplitude</measure>
      <time_frame>Day 1</time_frame>
      <description>Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Corneal hysteresis</measure>
      <time_frame>Day 1</time_frame>
      <description>Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Corneal resistance factor</measure>
      <time_frame>Day 1</time_frame>
      <description>Overall resistance of the cornea, measured using ORA [mmHg]</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intraocular pressure measured using Corvis ST</measure>
      <time_frame>Day 1</time_frame>
      <description>Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraocular pressure measured using ORA</measure>
      <time_frame>Day 1</time_frame>
      <description>Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pachymetry</measure>
      <time_frame>Day 1</time_frame>
      <description>Measure of corneal thickness using Corvis ST</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">0</enrollment>
    <condition>Eye Diseases</condition>
    <arm_group>
      <arm_group_label>Glaucoma</arm_group_label>
      <description>Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ocular hypertension</arm_group_label>
      <description>Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Keratoconus</arm_group_label>
      <description>Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Healthy</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Measurement of corneal biomechanical properties</intervention_name>
      <description>Measurement of corneal biomechanics</description>
      <arm_group_label>Glaucoma</arm_group_label>
      <arm_group_label>Healthy controls</arm_group_label>
      <arm_group_label>Keratoconus</arm_group_label>
      <arm_group_label>Ocular hypertension</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult population. Study group: patients at Birmingham and Midlands Eye Centre. Control&#xD;
          groups: healthy population recruited in Birmingham among staff and students at Aston&#xD;
          University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age above 18 years old.&#xD;
  &#xD;
            -  Participants who are able to give informed consent.&#xD;
  &#xD;
            -  Study groups: Patients with diagnosis of glaucoma or corneal disease or ocular&#xD;
               hypertension. Patients that are having a treatment (medications or surgery) for&#xD;
               glaucoma or ocular hypertension or corneal conditions.&#xD;
  &#xD;
            -  Control group: people with no diagnosis or treatment of previous pathologies.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age below 18.&#xD;
  &#xD;
            -  Participants who are not able to give informed consent.&#xD;
  &#xD;
            -  Patients with eye conditions not within the inclusion criteria.&#xD;
  &#xD;
            -  Patients with respiratory distress or significant head tremor.&#xD;
  &#xD;
            -  Patients who are in pain or unable to remain seated for duration of measurements.&#xD;
  &#xD;
            -  Participants that during the visit are wearing contact lenses. The wear of contact&#xD;
               lenses can alter the measure of corneal biomechanics.&#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>Shehzad A Naroo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aston University</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2022</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Machine Learning</keyword>
    <keyword>Glaucoma</keyword>
    <keyword>Keratoconus</keyword>
    <keyword>Ocular Hypertension</keyword>
    <keyword>Corneal Biomechanics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eye Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973617
  org study id: 005-2021-SN
  nct id: NCT05973617
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to use machine learning to develop an IT tool able to differentiate
        between eye conditions analysing corneal biomechanical data.
  Data will be collected using two different commercially available devices that are able to
        measure corneal biomechanics. Corneal biomechanics will be measured in participants with
        different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls
        as it is well established that the above-mentioned conditions cause changes in corneal
        biomechanical properties.
  
        Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and
        it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal
        Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to
        temporally flatten the cornea and derive the properties of the tissue.
  
        Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre
        (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine
        clinical appointment. Healthy controls will be recruited at Aston University. This study
        requires only one visit and there is no need of follow up.
  
        A portion of the data collected will be used to train machine learning algorithms to
        differentiate between conditions, the remaining data will be used to test the accuracy of
        newly created algorithms. The algorithm will be developed using Orange Data Mining.
  observational model: Cohort
  time perspective: Prospective
  measure: First applanation velocity
  time frame: Day 1
  description: Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]
  measure: First applanation time
  time frame: Day 1
  description: Time frame of the first applanation of the cornea, measured using Corivs ST [s]
  measure: First applanation lenght
  time frame: Day 1
  description: Lenght of the first applanation of the cornea, measured using Corivs ST [mm]
  measure: Second applanation velocity
  time frame: Day 1
  description: Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]
  measure: Second applanation time
  time frame: Day 1
  description: Time frame of the second applanation of the cornea, measured using Corivs ST [s]
  measure: Second applanation lenght
  time frame: Day 1
  description: Lenght of the second applanation of the cornea, measured using Corivs ST [mm]
  measure: Highest concavity time
  time frame: Day 1
  description: Time frame at highest concavity, measured using Corivs ST [s]
  measure: Highest concavity peak distance
  time frame: Day 1
  description: Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]
  measure: Highest concavity radius
  time frame: Day 1
  description: Radius of curvature at highest concavity, measured using Corivs ST [mm]
  measure: Highest concavity deformation amplitude
  time frame: Day 1
  description: Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]
  measure: Corneal hysteresis
  time frame: Day 1
  description: Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]
  measure: Corneal resistance factor
  time frame: Day 1
  description: Overall resistance of the cornea, measured using ORA [mmHg]
  measure: Intraocular pressure measured using Corvis ST
  time frame: Day 1
  description: Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.
  measure: Intraocular pressure measured using ORA
  time frame: Day 1
  description: Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.
  measure: Pachymetry
  time frame: Day 1
  description: Measure of corneal thickness using Corvis ST
  arm group label: Glaucoma
  description: Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma
  arm group label: Ocular hypertension
  description: Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension
  arm group label: Keratoconus
  description: Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus
  arm group label: Healthy controls
  description: Healthy
  intervention type: Diagnostic Test
  intervention name: Measurement of corneal biomechanical properties
  description: Measurement of corneal biomechanics
  arm group label: Glaucoma
  arm group label: Healthy controls
  arm group label: Keratoconus
  arm group label: Ocular hypertension
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shehzad A Naroo, PhD
  role: Principal Investigator
  affiliation: Aston University
  responsible party type: Sponsor
  mesh term: Eye Diseases
  sharing ipd: No