Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Coefficient of variation of tear film osmolarity after repeated measurements
研究概览
简要总结
Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.
Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with dry eye syndrome (DES):
- •Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
- •normal findings in the ophthalmic examination other than DES
- •Healthy control group:
- •Men and Women aged between 45 and 80 years,
- •normal findings in the medical history and ophthalmic examination
排除标准
- •Abuse of drugs or alcoholic beverages
- •Participation in a clinical trial
- •Symptoms of a clinically relevant illness
结局指标
主要结局
Coefficient of variation of tear film osmolarity after repeated measurements
时间窗: Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days
次要结局
- Subjective symptoms assessed using the OSDI test(on the screening day)
- Tear break up time(on 3 consecutive study days once a day)
- Schirmer I test(on 3 consecutive study days once a day)
- OSI (Objective Scattering Index)(on 3 consecutive study days once a day)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna