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Pseudoexfoliation and Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01693744
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
Leyla Niyaz, Corum State Hospital

Tracking Information
First Submitted Date September 20, 2012
First Posted Date September 26, 2012
Last Update Posted Date September 26, 2012
Study Start Date October 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 24, 2012)
Prevalance of pseudoexfoliation in patients with chronic kidney disease [ Time Frame: 7 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pseudoexfoliation and Chronic Kidney Disease
Official Title The Relationship Between Pseudoexfoliation and Chronic Kidney Disease
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients from nephrology clinic
Condition Chronic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts
  • Dialysis patients
    Patients with stage 5 chronic kidney disease undergoing haemodialysis
  • Chronic kidney disease patients
    Stage 1-4 Chronic kidney disease patients
  • Control group
    Patients with normal renal functions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2012)
358
Original Actual Enrollment Same as current
Actual Study Completion Date April 2012
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • All patients with chronic kidney disease stage 1-5

Exclusion Criteria:

  • History of eye trauma or surgery
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01693744
Other Study ID Numbers LNiyaz
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Leyla Niyaz, Corum State Hospital
Study Sponsor Corum State Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Leyla Niyaz, M.D. Specialist in Ophthalmology
PRS Account Corum State Hospital
Verification Date September 2012