The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inflammatory cell density
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Inflammatory cell density
时间窗: 1.5 years
次要结局
未报告次要终点