Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

• Conditions: Primary Sjogren's Syndrome

• Registration Number: NCT00920179
• Lead Sponsor: Keio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Last Update Submitted: 2009-06-12
• Study First Posted: 2009-06-15
• Last Update Posted: 2009-06-15
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory cell density	1.5 years

Trial Locations

Locations (1)

Keio University School of Medicine; 🇯🇵 Tokyo, Japan