Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

NCT ID: NCT00920179

Last Updated: 2009-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31

Brief Summary

Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.

Conditions

Primary Sjogren's Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dry eye group

Dry eye patients with Primary Sjogren's syndrome

No interventions assigned to this group

Controls

Healthy subjects without dry eyes

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria.
• Briefly, the patients had to have ocular and oral symptoms of dryness,
• clinically diagnosed dry eye and dry mouth disease,
• serum rheumatoid factor and antinuclear antibody levels ≥1:160,
• positive serology for anti SS-A or anti SS-B antibodies,
• labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study.

Exclusion Criteria

• Patients with any history of ocular surgery including punctal occlusion,
• other ocular or systemic disease
• or a history of topical/ systemic drug use or contact lens wear or
• other systemic disorders that would cause dry eyes or that would alter the ocular surface.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Keio University

OTHER

Sponsor Role: lead

Responsible Party

J&J Ocular Surface and Visual Optics Department

Principal Investigators

Kazuo Tsubota, Professor

Role: STUDY_DIRECTOR

Keio University

Locations

Keio University School of Medicine

Tokyo, , Japan

Countries

Japan

Other Identifiers

21071965

Identifier Type: -

Identifier Source: org_study_id