Ocular Surface Changes in Patients With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Bialystok.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Bialystok
ClinicalTrials.gov Identifier:
NCT00345280
First received: June 27, 2006
Last updated: June 16, 2008
Last verified: June 2008
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on August 28, 2014