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临床试验/NCT01496482
NCT01496482已完成不适用

Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

University of Zagreb1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008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
90
试验地点
1
主要终点
Tear evaporation

研究概览

简要总结

Purpose:

To establish whether there is a correlation between dry eye symptoms, age and gender, a difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and finally whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry).

Methods:

Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms.

Examination included structured case history (questionnaire), slit lamp examination with fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.

详细描述

Purpose:

The purpose of this study was to establish whether there is a correlation between dry eye symptoms, age and gender, any difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and, finally, whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry).

Methods:

Subjects were divided in two groups: 45 in group without dry eye related symptoms, and 45 in group with symptoms.

Examination was performed in the following sequence:

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 61 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with or without dry eye symptoms

排除标准

  • pregnant women
  • patients with acute eye conditions (inflammation, allergy, trauma)
  • patients with chronic eye diseases requiring continuous topical treatment (i.e.glaucoma)
  • ocular surface scarring
  • patients who did not sign informed consent.

结局指标

主要结局

Tear evaporation

时间窗: 10 minutes

Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.

次要结局

  • Comparison of tear evaporation to symptoms score(15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording))
  • Comparison of tear evaporation to Tear Film Break-up Time (TBUT)(15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement))
  • Comparison of tear evaporation to Schirmer test(15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test))
  • Comparison of tear evaporation to corneal staining(12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment))
  • Comparison of tear evaporation to conjunctival hyperemia(11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment))

研究者

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

Igor Petricek

Ophthalmologist, MD, PhD, Head of the Ocular Electrophysiology and Ultrasound Laboratory

University of Zagreb

研究点 (1)

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