Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tear cytokines levels
研究概览
简要总结
The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes
详细描述
In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.
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
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS>0)
- •type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
- •Willing to sign the consent form.
排除标准
- •Having known Eye infection, allergy, malformation, abnormal eye movement
- •Exclusion of eye injury, any kind of eye surgery
- •Exclusion of other disease may cause neuropathy or influence tear producing
- •Using systematic or local antibiotics that may influence tear producing
- •Elimianation Criteria
- •poor compliance
- •voluntary withdrawal
- •any other kind of situation that researchers consider not suitable for further study.
结局指标
主要结局
Tear cytokines levels
时间窗: through study completion,an average of two weeks
Comparision the tear cytokines （EGF, IL-17A, IL-1β, IL-8 and TNF-α）levels in different groups using using a Milliplex Map Kit (Human Th17 Magnetic Bead Panel, Millipore, Billerica, MA).
次要结局
- Clinical correlations of the tear cytokines(through study completion,an average of two weeks)
研究者
Hong Qi
MD.PHD.
Peking University Third Hospital