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临床试验/NCT02765308
NCT02765308已完成不适用

The Contribution of Altered Aqueous Dynamics in the Development of Raised Intraocular Pressure in Patients With Uveitis

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2013年8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
94
试验地点
1
主要终点
Facility of outflow

研究概览

简要总结

Uveitis is a disease that affects over 2 million people around the globe, and can ultimately lead to blindness. The proportion of patients with uveitis who become blind has not been reduced over the past 30 years, and this is therefore an area that demands further research. One of the major causes of blindness in uveitic patients is the development of uveitic glaucoma, which occurs in 10-20% of uveitic eyes. This is likely to occur for reasons related to the uveitis itself, but can also be caused as a side effect of the corticosteroids used to treat uveitis. The raised IOP in uveitis is more difficult to treat than other types of glaucoma.

To enable more effective treatment of uveitic glaucoma, the investigators need to understand more clearly the mechanisms which underlie this process. The investigators therefore propose a study to examine the contribution of altered aqueous dynamics to the development of raised IOP in uveitis.

详细描述

The investigators propose to undertake a cross-sectional observational study of patients with recurrent idiopathic acute anterior uveitis, to determine the relative contributions of altered aqueous production and drainage to the development of raised IOP in these patients.

Methods

Study Design A cross sectional observational study

Patient Selection All subjects attending the uveitis and glaucoma clinics at St Thomas' Hospital will be eligible to be included in the study if they fulfil the inclusion/exclusion criteria as below.

30 patients will be included from each of these three group of patients: 1) recurrent (> 5 attacks) idiopathic acute anterior uveitic with raised intraocular pressure; 2) recurrent (> 5 attacks) idiopathic acute anterior uveitic without raised intraocular pressure; 3) healthy age matched volunteers as controls. Patients on glaucoma treatment will be washed out for one month before measurement.

研究设计

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

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

  • Patients with idiopathic recurrent anterior uveitis with or without raised IOP.
  • Normal healthy subjects with no ocular problems (other than refractive error) and IOP at screening < 21mmHg.
  • Age >18 years.
  • Adequate cognitive function and ability to understand verbal and written information in English.

排除标准

  • Other secondary glaucomas including pigment dispersion syndrome and pseudoexfoliation.
  • Normotensive glaucoma.
  • Primary angle closure.
  • Ocular trauma.
  • Intraocular or keratorefractive surgery.
  • Use of systemic medication that may affect aqueous humour production such as beta-blockers.
  • A history of allergy or hypersensitivity to fluorescein.
  • Any abnormalities preventing reliable IOP or fluorophotometric readings.

结局指标

主要结局

Facility of outflow

时间窗: day 1 only (study completion)

Tonographic outflow facility (C) will be performed using an electronic Schiøtz tonographer (Model 720, Berkeley Bioengineering Inc, USA) at 10AM

Rate of aqueous flow (measured by fluorophotometry).

时间窗: Four times during the morning through day 1 only (study completion)

Fluorophotometry will be performed in both eyes using a scanning ocular fluorophotometer from 9AM to 12PM (FM-2, Fluorotron Master Ocular Fluorophotometer; OcuMetrics, Mountain View, California). The aqueous turnover protocol will be used to calculate the aqueous flow rate. Duplicate or triplicate scans will be collected and repeated at 1 hour intervals for 4 measurements to determine the aqueous flow rate (Ft).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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