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临床试验/NCT05605314
NCT05605314招募中不适用

Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
ESSDAI

研究概览

简要总结

Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.

详细描述

Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.

排除标准

  • (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pSS and DED. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.

结局指标

主要结局

ESSDAI

时间窗: 2021.1~2028.1

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次要结局

  • BUT,TMH(2021.1~2028.1)
  • Schirmer(2021.1~2028.1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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