Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920179
Recruitment Status : Unknown
Verified June 2009 by Keio University.
Recruitment status was:  Enrolling by invitation
First Posted : June 15, 2009
Last Update Posted : June 15, 2009
Information provided by:
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.

Condition or disease
Primary Sjogren's Syndrome

Study Type : Observational
Estimated 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 : October 2007
Estimated Primary Completion Date : December 2010

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U.S. FDA Resources

Dry eye group
Dry eye patients with Primary Sjogren's syndrome
Healthy subjects without dry eyes

Primary Outcome Measures :
  1. Inflammatory cell density [ Time Frame: 1.5 years ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary SS and healthy controls

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00920179

Keio University School of Medicine
Tokyo, Japan, 1608582
Sponsors and Collaborators
Keio University
Study Director: Kazuo Tsubota, Professor Keio University

Responsible Party: Associate Professor Dr Murat Dogru, J&J Ocular Surface and Visual Optics Department Identifier: NCT00920179     History of Changes
Other Study ID Numbers: 21071965
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by Keio University:
dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland

Additional relevant MeSH terms:
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases