Ocular Surface Changes in Patients With Cystic Fibrosis - Full Text View

Sponsor:	University of Bialystok
Information provided by:	University of Bialystok
ClinicalTrials.gov Identifier:	NCT00345280

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 I

Study Type:	Observational
Study Design:	Cohort, 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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by University of Bialystok:

Biospecimen Retention: None Retained

Biospecimen Description:

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

Intervention Details:

Vitamin A

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

Ages Eligible for Study:	3 Years to 25 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Medical University of Bialystok, Poland ( Malgorzata Mrugacz )
Study ID Numbers:	8789, N40605131/1894
Study First Received:	June 27, 2006
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00345280 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by University of Bialystok:

Cystic fibrosis
eye
inflammation
apoptosis
C11+

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Eye Diseases
Lung Diseases
Eye Manifestations
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 30, 2009