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Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

Sponsor
Keio University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00920179
Collaborator
(none)
30
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome
    Study Start Date :
    Oct 1, 2007
    Anticipated Primary Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Dry eye group

    Dry eye patients with Primary Sjogren's syndrome
    Controls

    Healthy subjects without dry eyes

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory cell density [1.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keio University School of Medicine Tokyo Japan 1608582

    Sponsors and Collaborators

    • Keio University

    Investigators

    • Study Director: Kazuo Tsubota, Professor, Keio University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00920179
    Other Study ID Numbers:
    • 21071965
    First Posted:
    Jun 15, 2009
    Last Update Posted:
    Jun 15, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jun 15, 2009