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Ocular Surface Changes in Patients With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Bialystok.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345280
First Posted: June 28, 2006
Last Update Posted: June 17, 2008
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.
Information provided by:
University of Bialystok
  Purpose
Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow determination of immunological exponents which may facilitate diagnosis.

Condition Intervention Phase
Eye Manifestations Procedure: impression cytology, obtain the tear fluid Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Bialystok:

Estimated Enrollment: 26
Study Start Date: August 2006
Estimated Study Completion Date: September 2008
Intervention Details:
    Procedure: impression cytology, obtain the tear fluid
    Vitamin A
    Other Name: Becton Dickinson
Detailed Description:
The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
26 male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
Criteria

Inclusion Criteria:

  • male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
  • all patients must give written consent for participation in the study at screening

Exclusion Criteria:

  • patients with a history of chronic disease of the immune system
  • patients with the history of systemic diseases
  • patients with the history chronic ocular diseases
  • patients who have been treated with corticosteroids in the past 3 months prior to the screening visit
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345280


Contacts
Contact: Michal Sewerynski, Prof. +48 22 6281944 minister@mnisw.gov.pl

Locations
Poland
Medical University Recruiting
Bialystok, Poland, 15- 089
Contact: Andruszkiewicz       dzialnauki@amb.edu.pl   
Sponsors and Collaborators
University of Bialystok
Investigators
Principal Investigator: Malgorzata Mrugacz, MD, PhD Department of Pediatric Ophthalmology Medical University of Bialystok, Poland
  More Information

Responsible Party: Malgorzata Mrugacz, Medical University of Bialystok, Poland
ClinicalTrials.gov Identifier: NCT00345280     History of Changes
Other Study ID Numbers: 8789
N40605131/1894
First Submitted: June 27, 2006
First Posted: June 28, 2006
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by University of Bialystok:
Cystic fibrosis
eye
inflammation
apoptosis
C11+

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Eye Manifestations
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Eye Diseases
Signs and Symptoms