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Ocular Surface Changes in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00345280
Recruitment Status : Unknown
Verified June 2008 by University of Bialystok.
Recruitment status was:  Recruiting
First Posted : June 28, 2006
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
University of Bialystok

Brief Summary:
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 or disease Intervention/treatment
Eye Manifestations Procedure: impression cytology, obtain the tear fluid

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.

Study Type : Observational
Estimated Enrollment : 26 participants
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
Study Start Date : August 2006
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis


Intervention Details:
  • Procedure: impression cytology, obtain the tear fluid
    Vitamin A
    Other Name: Becton Dickinson



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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

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

Responsible Party: Malgorzata Mrugacz, Medical University of Bialystok, Poland
ClinicalTrials.gov Identifier: NCT00345280     History of Changes
Other Study ID Numbers: 8789
N40605131/1894
First Posted: June 28, 2006    Key Record Dates
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