<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/NCT04464083</url>
  </required_header>
  <id_info>
    <org_study_id>R110</org_study_id>
    <nct_id>NCT04464083</nct_id>
  </id_info>
  <brief_title>IOP Measurements Using ORA After ACXL in Keratoconus</brief_title>
  <official_title>Intraocular Pressure Measurements Using Ocular Response Analyzer After Accelerated Corneal Collagen Crosslinking With Riboflavin and Ultraviolet A in Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months&#xD;
      after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance&#xD;
      factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2020</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determine IOP readings before and after accelerated corneal collagen crosslinking</measure>
    <time_frame>April-October 2020</time_frame>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IOP Measurment</intervention_name>
    <description>To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients with KC and indicated for CXL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  KC patient indicated for CXL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced KC Glaucoma patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>February 2021</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</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>Undecided</sharing_ipd>
    <ipd_description>approval from the principal investigator</ipd_description>
  </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/NCT04464083
org study id: R110
nct id: NCT04464083
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months
      after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance
      factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.
observational model: Case-Only
time perspective: Prospective
measure: To determine IOP readings before and after accelerated corneal collagen crosslinking
time frame: April-October 2020
intervention type: Diagnostic Test
intervention name: IOP Measurment
description: To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Undecided
ipd description: approval from the principal investigator