<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/NCT01693744</url>
  </required_header>
  <id_info>
    <org_study_id>LNiyaz</org_study_id>
    <nct_id>NCT01693744</nct_id>
  </id_info>
  <brief_title>Pseudoexfoliation and Chronic Kidney Disease</brief_title>
  <official_title>The Relationship Between Pseudoexfoliation and Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corum State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corum State Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material&#xD;
      in an eye structures and many other parts of the body including kidneys and blood vessels. As&#xD;
      both PEX and chronic kidney disease (CKD) are associated with oxidative stress and&#xD;
      endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.&#xD;
&#xD;
      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic&#xD;
      kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60&#xD;
      mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,&#xD;
      group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal&#xD;
      kidney functions (control group). Demographic properties and the rate of PEX were evaluated&#xD;
      and compaired between the groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">April 2012</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>Prevalance of pseudoexfoliation in patients with chronic kidney disease</measure>
    <time_frame>7 months</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">358</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Dialysis patients</arm_group_label>
    <description>Patients with stage 5 chronic kidney disease undergoing haemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic kidney disease patients</arm_group_label>
    <description>Stage 1-4 Chronic kidney disease patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients with normal renal functions</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from nephrology clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with chronic kidney disease stage 1-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of eye trauma or surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leyla Niyaz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Specialist in Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corum State Hospital</name>
      <address>
        <city>Corum</city>
        <zip>19000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corum State Hospital</investigator_affiliation>
    <investigator_full_name>Leyla Niyaz</investigator_full_name>
    <investigator_title>Ophthalmology Specialist</investigator_title>
  </responsible_party>
  <keyword>Pseudoexfoliation, chronic kidney disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT01693744
org study id: LNiyaz
nct id: NCT01693744
lead sponsor: 
has dmc: Yes
Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material
      in an eye structures and many other parts of the body including kidneys and blood vessels. As
      both PEX and chronic kidney disease (CKD) are associated with oxidative stress and
      endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.

      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic
      kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60
      mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,
      group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal
      kidney functions (control group). Demographic properties and the rate of PEX were evaluated
      and compaired between the groups.
observational model: Case-Control
time perspective: Prospective
measure: Prevalance of pseudoexfoliation in patients with chronic kidney disease
time frame: 7 months
arm group label: Dialysis patients
description: Patients with stage 5 chronic kidney disease undergoing haemodialysis
arm group label: Chronic kidney disease patients
description: Stage 1-4 Chronic kidney disease patients
arm group label: Control group
description: Patients with normal renal functions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leyla Niyaz, M.D.
role: Principal Investigator
affiliation: Specialist in Ophthalmology
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Corum State Hospital
investigator full name: Leyla Niyaz
investigator title: Ophthalmology Specialist
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic