<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/NCT04462991</url>
  </required_header>
  <id_info>
    <org_study_id>M 354</org_study_id>
    <nct_id>NCT04462991</nct_id>
  </id_info>
  <brief_title>COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER</brief_title>
  <official_title>COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sara Tawfik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fayoum University</source>
  <brief_summary>
    <textblock>
      The purpose of current study is to provide a comprehensive comparison of the reliability of&#xD;
      corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging&#xD;
      using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>16 Weeks</target_duration>
  <primary_outcome>
    <measure>Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER</measure>
    <time_frame>we will recruit patients who meer the inclusion criteria during the study period januray-August 2020</time_frame>
    <description>In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .&#xD;
KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>The Reliability of Corneal Topographic Measurements of Keratoconus Eyes</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>corneal topography</intervention_name>
    <description>In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        keratoconus patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  topography characteristic of keratoconus (skewed asymmetric bow-tie, inferior steep&#xD;
             spot, etc.) and at least one clinical sign e.g., slit lamp findings of Munson's sign,&#xD;
             Vogt's striae, Fleischer's ring, apical thinning, Rizutti's sign, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are advanced complications of keratoconus such as corneal scars or hydrops.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fayoum University</name>
      <address>
        <city>Fayoum</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>Keratoconus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04462991
org study id: M 354
nct id: NCT04462991
lead sponsor: 
collaborator: 
The purpose of current study is to provide a comprehensive comparison of the reliability of
      corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging
      using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.
observational model: Case-Control
time perspective: Prospective
measure: Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
time frame: we will recruit patients who meer the inclusion criteria during the study period januray-August 2020
description: In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .
KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
intervention type: Diagnostic Test
intervention name: corneal topography
description: In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Fayoum University
investigator full name: Omar Said
investigator title: Assistant professor of ophthalmology
mesh term: Keratoconus
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)