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临床试验/NCT02774707
NCT02774707Unknown不适用

Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye

研究概览

简要总结

Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.

详细描述

Dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. Traditional treatment was mainly focused on artificial tear supplement. Inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. Anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye.

Conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. Therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. Clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye.

However, in the manufacture of autologous serum, it is hard to standardize every step and control quality. What's more, the patient may have different etiology of dry eye, including primary Sjogren's syndrome, secondary Sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. The etiology of dry eye may have different response to autologous serum. However, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. This is what we want to know in this study.

Since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。

研究设计

研究类型
Observational
时间视角
Cross Sectional

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye

时间窗: 1 year

We would measure Epidermal growth factor concentration (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye

时间窗: 1 year

We would measure Transforming growth factor beta (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye

时间窗: 1 year

We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye

时间窗: 1 year

We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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