Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

NCT00920179 | Unknown

• 1 other identifier: 21071965
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjogren's Syndrome

Keywords

dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland

Outcome Measures

Primary Outcomes (1)

• Inflammatory cell density

  1.5 years

Study Arms (2)

Dry eye group

Dry eye patients with Primary Sjogren's syndrome

Controls

Healthy subjects without dry eyes

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary SS and healthy controls

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keio University: lead

Study Sites (1)

Keio University School of Medicine

Tokyo, 1608582, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Inflammation

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazuo Tsubota, Professor

  Keio University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

JP (1)