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临床试验/NCT01988597
NCT01988597已完成不适用

Dry Eye Symptoms and Quality of Life

Singapore National Eye Centre1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
• Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient health related quality of life (HRQOL)

研究概览

简要总结

Dry eye syndrome is a very common condition with multiple etiologies that includes systemic and ocular disease that causes reduction in the production of tears, as well as increase in tears evaporation. As a result of the various etiologies and large variability of dry eye's clinical sign, it has been a challenge for practitioners to have a consistent system to classify dry eyes and to have an appropriate and accurate measurement to quantify the severity of dry eyes and its impact on patients' quality of life.6 To date, no study which evaluates the extent of questionnaires correlates with changes in quality of life. With this cross sectional interview study, we aim to determine the efficacy of the questionnaires as a practical tool in our future clinical trials at our center.

详细描述

Dry eye is a multifactorial condition that affects 5-35% of the population.1 Common symptoms of this condition include eye irritation, heaviness of the eyelids, visual disturbances, tearing and light sensitivity.2 This condition significantly decrease patient health related quality of life (HRQOL). Clinical studies shown poor correlation between clinical test symptoms and self perceived severity of the disease.7 Studies also have shown that utilities of more severe dry eye similar to condition such as class III/IV angina affecting the QOL.6 Correlation between reduce quality of life and presenting symptoms is unknown compared to other factors such as cost and inconvenience of treatment. This implicates on the management of the condition. In addition, there is a significant socioeconomic burden. In 2009, 54,051 patients sought treatment for dry eye in the Singapore National Eye Centre (SNEC). In total, the costs for dry eye medication amounted to $181,354.17.4

Although different questionnaires have been used in assessment of dry eye, to date, there has been no study which evaluates the extent of questionnaires correlate with change in quality of life.

This is particularly important since symptoms of dry eyes are episodic and questionnaires administered at one time point may or may not reflect the true disease morbidity. Two of such questionnaires are the SPEED questionnaires which consist of 2 questions graded on a scale of 0-3 on frequency and grade 0-4 on severity and SANDE questionnaires which consist of 3 questions based on symptoms of frequency and severity.

Both of the questionnaires have been published and validated and utilized in the eye clinic by the investigators.

Over the last few years, SNEC/SERI has built up a dedicated team of dry eye researchers for trials and evaluation of diagnostic devices. There is an increasing interest internationally, especially from industry, to partner us for testing of commercial products.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 21 years old and above and has full legal capacity to volunteer
  • Patients able to understand and complete 2 English questionnaires.
  • Symptomatic dry eye patient

排除标准

  • Any other specified reason as determined by clinical investigator.

结局指标

主要结局

• Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient health related quality of life (HRQOL)

时间窗: 1 day

• Difference in both (SPEED and SANDE) questionnaires and utility values that affects patient health related quality of life (HRQOL)

时间窗: 1 day

次要结局

  • Production of Tear flow(1 day)
  • Tear break up time (TBUT)(1 day)
  • Corneal flourescein staining(1 day)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Louis Tong

Clinician-Scientist, Senior Consultant

Singapore National Eye Centre

研究点 (1)

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