Correlation of Different Signs for Assessment of Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Break up time
研究概览
简要总结
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.
The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •History of dry eye syndrome for at least 3 months
- •At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds
- •Normal ophthalmic findings except dry eye syndrome
排除标准
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Wearing of contact lenses
- •Intake of dietary supplements in the 3 months preceding the study
- •Treatment with corticosteroids in the 4 weeks preceding the study
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
- •Ocular infection or clinically significant inflammation
- •Ocular surgery in the 3 months preceding the study
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •Pregnancy, planned pregnancy or lactating
结局指标
主要结局
Break up time
时间窗: once on the study day
break up time of the tear film measured in seconds
Tear film thickness as measured with optical coherence tomography (OCT)
时间窗: once on the study day
tear film thickness measured in micrometers
次要结局
- Subjective symptoms of dry eye syndrome(once on the study day)
- Visual Acuity(once on the study day)
- Tear film osmolarity(once on the study day)
- OSI (Objective Scattering Index)(once on the study day)
- Staining of the cornea with fluorescein(once on the study day)
- Impression cytology(once on the study day)
- Tear cytokines/chemokines(once on the study day)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna