Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Sjogren's Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1608582
    • Keio University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary SS and healthy controls

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Dry eye group; Dry eye patients with Primary Sjogren's syndrome
Controls; Healthy subjects without dry eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inflammatory cell density	1.5 years

Collaborators and Investigators

• Sponsor: Keio University
• Investigators: Study Director: Kazuo Tsubota, Professor, Keio University

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): December 1, 2010
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2009
• Last Update Submitted That Met QC Criteria: June 12, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 21071965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No