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临床试验/NCT05075369
NCT05075369Unknown不适用

Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

University of Manitoba0 个研究点目标入组 20 人开始时间: 2021年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Change in baseline intraocular pressure(IOP) with water drinking test

研究概览

简要总结

Disc hemorrhages are a known risk factor for progression of glaucoma. A positive water drinking test is also associated with progression of primary open glaucoma. The purpose of this study is to determine if patients with normal tension glaucoma and disc hemorrhages have a positive water drinking test.

Patients with normal tension glaucoma and a disc hemorrhage will be recruited to undergo a water drinking test prior to any change in their treatment.

详细描述

Patient with normal tension glaucoma under the care of a fellowship trained glaucoma specialist and noted to have a disc hemorrhage in one or both eyes when examined in the office will be recruited to undergo a water drinking test (WDT). After an informed consent is obtained, arrangements will be made to undergo the WDT either at the ophthalmologist's office or the local hospital clinic(Misericordia). The test will be administered in the following way:

Upon arrival the patients baseline intraocular pressure (IOP) will be measured, then shortly afterwards the patient will drink 800 ml of water in a period of 5 minutes. Immediately after the water ingestion has finished a second IOP will be measured, followed by IOP measurements every 15 minutes for 60 minutes with a Goldman applanation tonometer by the same examiner. All of these measurements will be collected in a data sheet for the WTD. A total of 60 minutes would be the duration of the activity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Clinical diagnosis of normal tension glaucoma by a fellowship trained glaucoma specialist,
  • Clinical diagnosis of a disc hemorrhage diagnosed by a fellowship trained glaucoma specialist,
  • Must be able to swallow water
  • Must be able to be positioned to allow accurate measurement of the Intraocular pressure with a slit lamp mounted Goldmann applanation tonometer
  • Must have a smooth corneal surface to allow for accurate Goldmann application tonometry measurement
  • Outpatient
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel

排除标准

  • History of refractive surgery,
  • Active ocular infection,
  • Pregnancy,
  • Cardiac or renal diseases, history of urinary retention,
  • Corneal abnormalities preventing reliable IOP measurements,
  • Previous trabeculectomy or glaucoma shunt surgery,
  • Previous laser iridotomy,
  • Cognitive impairment or language barrier preventing ability to provide an informed consent.

结局指标

主要结局

Change in baseline intraocular pressure(IOP) with water drinking test

时间窗: The water drinking test takes 60 minutes, and the participant is then finished and can leave.

The change in intraocular pressure in patients with normal tension glaucoma and a disc hemorrhage after undergoing the water drinking test will be measured with Goldmann applanation tonometry. A change from baseline IOP of 5 mm Hg is considered abnormal .

次要结局

未报告次要终点

研究者

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

Lisa Gould

Lisa Gould Associate Professor

University of Manitoba

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