A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Correlation between tear fluid iron concentration and dry eye symptom severity
研究概览
简要总结
This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 70 years, inclusive.
- •Willing and able to provide written informed consent.
排除标准
- •History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic/renal insufficiency.
- •Use of artificial tears or any topical eye drops within 2 hours prior to examination.
- •Active ocular allergy, infection, or severe blepharitis within the past 1 month.
- •Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month.
- •History of contact lens wear within the past 1 month.
- •History of blood transfusion, ocular surgery, or significant ocular trauma within the past 6 months.
- •Women who are pregnant, breastfeeding, or postmenopausal women undergoing hormone replacement therapy.
- •Known hypersensitivity to fluorescein sodium.
研究组 & 干预措施
CON
干预措施: Diagnostic tear fluid collection and ocular surface evaluation (Procedure)
DED
干预措施: Diagnostic tear fluid collection and ocular surface evaluation (Procedure)
结局指标
主要结局
Correlation between tear fluid iron concentration and dry eye symptom severity
时间窗: baseline
The strength of association between the concentration of iron (in μg/mL) in tear fluid collected via Schirmer strips and the total score on the Ocular Surface Disease Index (OSDI) questionnaire.
次要结局
- Correlation between tear fluid iron concentration and tear film stability(baseline)
- Correlation between tear fluid iron concentration and tear secretion volume(baseline)
- Correlation between tear fluid iron concentration and corneal epithelial damage(baseline)
研究者
Ruili Wei
Chief of Ophthalmology
Shanghai Changzheng Hospital