NCT01693744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

First QC Date

September 20, 2012

Last Update Submit

September 24, 2012

Conditions

Keywords

Pseudoexfoliation, chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Prevalance of pseudoexfoliation in patients with chronic kidney disease

    7 months

Study Arms (3)

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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from nephrology clinic

You may qualify if:

  • All patients with chronic kidney disease stage 1-5

You may not qualify if:

  • History of eye trauma or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corum State Hospital

Çorum, 19000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leyla Niyaz, M.D.

    Specialist in Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology Specialist

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

October 1, 2011

Study Completion

April 1, 2012

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations