Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Keio University
ClinicalTrials.gov Identifier:
NCT00920179
First received: June 12, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Primary Sjogren's Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Keio University:

Primary Outcome Measures:
  • Inflammatory cell density [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dry eye group
Dry eye patients with Primary Sjogren's syndrome
Controls
Healthy subjects without dry eyes

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary SS and healthy controls

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920179

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

No publications provided

Responsible Party: Associate Professor Dr Murat Dogru, J&J Ocular Surface and Visual Optics Department
ClinicalTrials.gov Identifier: NCT00920179     History of Changes
Other Study ID Numbers: 21071965
Study First Received: June 12, 2009
Last Updated: June 12, 2009
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014