Status:
UNKNOWN
Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome
Lead Sponsor:
Keio University
Conditions:
Primary Sjogren's Syndrome
Eligibility:
All Genders
20-80 years
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, eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00920179
Start Date
October 1 2007
Last Update
June 15 2009
Active Locations (1)
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1
Keio University School of Medicine
Tokyo, Japan, 1608582