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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01693744
Other study ID # LNiyaz
Secondary ID
Status Completed
Phase N/A
First received September 20, 2012
Last updated September 24, 2012
Start date October 2011
Est. completion date April 2012

Study information

Verified date September 2012
Source Corum State Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 358
Est. completion date April 2012
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- All patients with chronic kidney disease stage 1-5

Exclusion Criteria:

- History of eye trauma or surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Turkey Corum State Hospital Corum

Sponsors (1)

Lead Sponsor Collaborator
Corum State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalance of pseudoexfoliation in patients with chronic kidney disease 7 months No
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