Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

Primary Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00920179
• Other study ID #: 21071965
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 12, 2009
• Last updated: June 12, 2009
• Start date: October 2007

Study information

• Verified date: June 2009
• Source: Keio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Primary Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
Japan	Keio University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cell density		1.5 years	No