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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00920179

Enrollment

Registered

2009-06-15

Start date

2007-10-31

Completion date

Unknown

Last updated

2009-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren's Syndrome

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Inflammatory cell density	1.5 years

Countries

Japan

Outcome results