Ocular Surface Changes in Patients With Cystic Fibrosis

NCT ID: NCT00345280

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eye Manifestations

Keywords

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Cystic fibrosis eye inflammation apoptosis C11+

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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impression cytology, obtain the tear fluid

Vitamin A

Intervention Type PROCEDURE

Other Intervention Names

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Becton Dickinson

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bialystok

OTHER_GOV

Sponsor Role lead

Responsible Party

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Medical University of Bialystok, Poland

Principal Investigators

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Malgorzata Mrugacz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Ophthalmology Medical University of Bialystok, Poland

Locations

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Medical University

Bialystok, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Michal Sewerynski, Prof.

Role: CONTACT

Phone: +48 22 6281944

Email: [email protected]

Facility Contacts

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Andruszkiewicz

Role: primary

Other Identifiers

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N40605131/1894

Identifier Type: -

Identifier Source: secondary_id

8789

Identifier Type: -

Identifier Source: org_study_id