<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/NCT03265457</url>
  </required_header>
  <id_info>
    <org_study_id>PXF</org_study_id>
    <nct_id>NCT03265457</nct_id>
  </id_info>
  <brief_title>The Endothelial Count in Pxf</brief_title>
  <official_title>The Corneal Endothelial Cell Count in Eyes With Pseudoexfoliation Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of&#xD;
      coexisting cataract and glaucoma. It may be associated with a less than normal endothelial&#xD;
      count.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The corneal Endothelium is essential for the maintenance of normal corneal hydration,&#xD;
      thickness, and transparency.&#xD;
&#xD;
      In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological&#xD;
      changes of the corneal endothelium have been demonstrated in specular and electron&#xD;
      microscopic studies.&#xD;
&#xD;
      Specular microscopy is a non-invasive technique to access the structure and function of the&#xD;
      corneal endothelium.&#xD;
&#xD;
      Our research question is to study Endothelial cell count in patients with pseudoexfoliation&#xD;
      syndrome &amp; compare it to age matched group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</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>Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.</measure>
    <time_frame>One year</time_frame>
    <description>The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy &amp; compared with the normal endothelial count in people at the same group</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pseudoexfoliation Syndrome</condition>
  <arm_group>
    <arm_group_label>patient with pseudoexfoliation syndrome</arm_group_label>
    <description>The corneal Endothelial cell count will be measured by specular microscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal people at same age</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specular microscopy</intervention_name>
    <description>Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group</description>
    <arm_group_label>Normal people at same age</arm_group_label>
    <arm_group_label>patient with pseudoexfoliation syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pseudoexfoliation syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pseudoexfoliation syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous intra ocular surgeries.&#xD;
&#xD;
          -  Patients with uveitis&#xD;
&#xD;
          -  Patients with fuck's endothelial dystrophy&#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>
  <reference>
    <citation>Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.</citation>
    <PMID>2750833</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amira Asem</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exfoliation Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03265457
org study id: PXF
nct id: NCT03265457
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of
      coexisting cataract and glaucoma. It may be associated with a less than normal endothelial
      count.
The corneal Endothelium is essential for the maintenance of normal corneal hydration,
      thickness, and transparency.

      In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological
      changes of the corneal endothelium have been demonstrated in specular and electron
      microscopic studies.

      Specular microscopy is a non-invasive technique to access the structure and function of the
      corneal endothelium.

      Our research question is to study Endothelial cell count in patients with pseudoexfoliation
      syndrome & compare it to age matched group.
observational model: Case-Control
time perspective: Prospective
measure: Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.
time frame: One year
description: The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy & compared with the normal endothelial count in people at the same group
arm group label: patient with pseudoexfoliation syndrome
description: The corneal Endothelial cell count will be measured by specular microscopy
arm group label: Normal people at same age
intervention type: Other
intervention name: Specular microscopy
description: Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group
arm group label: Normal people at same age
arm group label: patient with pseudoexfoliation syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.
PMID: 2750833
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amira Asem
investigator title: Principal investigator
mesh term: Exfoliation Syndrome
mesh term: Syndrome