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Clinical Trials/NCT00920179
NCT00920179
Unknown
Not Applicable

The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome

Keio University1 site in 1 country30 target enrollmentOctober 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Sjogren's Syndrome
Sponsor
Keio University
Enrollment
30
Locations
1
Primary Endpoint
Inflammatory cell density
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
December 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Inflammatory cell density

Time Frame: 1.5 years

Study Sites (1)

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