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/NCT06000150</url>
    </required_header>
    <id_info>
      <org_study_id>M356</org_study_id>
      <nct_id>NCT06000150</nct_id>
    </id_info>
    <brief_title>Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital</brief_title>
    <acronym>Trachoma</acronym>
    <official_title>Characteristics of Trachomatous Corneal Opacity in Fayoum University Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Omar Said</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</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 to assess the characteristics of trachomatous corneal opacity in&#xD;
        patients with signs of trachoma using Anterior segment Optic coherence tomography and&#xD;
        Pentacam&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After approval of the local institutional ethics committee and local institutional review&#xD;
        board, patient presented to Fayoum University Hospital was examined for corneal opacity with&#xD;
        signs of trachoma after a detailed informed consent was signed by eligible patients and&#xD;
        investigated by Anterior Segment Optic coherence Tomography and Pentacam.&#xD;
  &#xD;
        Descriptive statistics were presented in the form of mean and standard deviation for&#xD;
        numerical variables while numbers and percentages are used for the categorical variables.&#xD;
  &#xD;
        Paired samples t-test was used to study anterior segment Optic Coherence tomography and&#xD;
        pentacam in evaluating corneal thickness. Bland-Altman plot was used to study the agreement&#xD;
        between the two methods IBM SPSS version 28 for Windows software was used for the analysis&#xD;
        and Stata 16 was used for the Bland-Altman plot. A p-value of &lt; 0.05 was considered&#xD;
        significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">August 30, 2022</completion_date>
    <primary_completion_date type="Actual">August 30, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Corneal imaging</measure>
      <time_frame>we will recruit patients who meer the inclusion criteria during the study period february-August 2022</time_frame>
      <description>AS-OCT and PENTACAM in patients with trachomatous corneal opacity</description>
    </primary_outcome>
    <enrollment type="Actual">50</enrollment>
    <condition>Corneal Opacity</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Corneal topography</intervention_name>
      <description>AS-OCT,PENTACAM</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with trachomatous corneal opacity&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with corneal opacity accompanied by signs of trachoma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  corneal opacity due other causes&#xD;
  &#xD;
            -  history of corneal surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fayoum University</name>
        <address>
          <city>Fayoum</city>
          <zip>63514</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Omar Said</investigator_full_name>
      <investigator_title>Assistant Professor of Ophthalmology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Corneal Opacity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06000150
  org study id: M356
  nct id: NCT06000150
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to assess the characteristics of trachomatous corneal opacity in
        patients with signs of trachoma using Anterior segment Optic coherence tomography and
        Pentacam
  After approval of the local institutional ethics committee and local institutional review
        board, patient presented to Fayoum University Hospital was examined for corneal opacity with
        signs of trachoma after a detailed informed consent was signed by eligible patients and
        investigated by Anterior Segment Optic coherence Tomography and Pentacam.
  
        Descriptive statistics were presented in the form of mean and standard deviation for
        numerical variables while numbers and percentages are used for the categorical variables.
  
        Paired samples t-test was used to study anterior segment Optic Coherence tomography and
        pentacam in evaluating corneal thickness. Bland-Altman plot was used to study the agreement
        between the two methods IBM SPSS version 28 for Windows software was used for the analysis
        and Stata 16 was used for the Bland-Altman plot. A p-value of < 0.05 was considered
        significant.
  observational model: Case-Control
  time perspective: Prospective
  measure: Corneal imaging
  time frame: we will recruit patients who meer the inclusion criteria during the study period february-August 2022
  description: AS-OCT and PENTACAM in patients with trachomatous corneal opacity
  intervention type: Diagnostic Test
  intervention name: Corneal topography
  description: AS-OCT,PENTACAM
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fayoum University
  investigator full name: Omar Said
  investigator title: Assistant Professor of Ophthalmology
  mesh term: Corneal Opacity
  sharing ipd: Undecided