Ocular Surface Changes in Patients With Cystic Fibrosis

Eye Manifestations Clinical Trial

Official title:

Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00345280
• Other study ID #: 8789
• Secondary ID: N40605131/1894
• Status: Recruiting
• Phase: Phase 1
• First received: June 27, 2006
• Last updated: June 16, 2008
• Start date: August 2006
• Est. completion date: September 2008

Study information

• Verified date: June 2008
• Source: University of Bialystok
• Contact: Michal Sewerynski, Prof.
• Phone: +48 22 6281944
• Email: minister[@]mnisw.gov.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 25 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Eye Manifestations

Intervention

Procedure:
• impression cytology, obtain the tear fluid
Vitamin A

Locations

Country	Name	City	State
Poland	Medical University	Bialystok

Sponsors (1)

Lead Sponsor	Collaborator
University of Bialystok

Country where clinical trial is conducted

Poland,