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临床试验/NCT02665884
NCT02665884Unknown不适用

Diurnal Fluctuations of Intraocular Pressure in EX-Press Valve Blebs in Glaucoma Patients

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Comparison of diurnal fluctuations of intraocular pressure

研究概览

简要总结

Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients

Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Open-angle glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level that the physician believes will prevent further glaucomatous damage. However, in a significant proportion of patients, the visual fields continue to deteriorate in spite of office pressures within the range of normal values (8). It has been suggested that the progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability not detected by tonometry during office hours. It is possible that certain drugs or surgical interventions are more effective than others in dampening these fluctuations. The purpose of our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with medications or Ex-press filtration surgery.

详细描述

Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients

Department of Ophthalmology, Hillel-Yaffe Medical Center, affiliated with the Bruce Rappaport School of Medicine, The Technion, Haifa, Israel

Introduction:

Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Medication alone is sometimes not sufficient to reduce excessively high IOP, and pharmaceutical intolerance may develop or damage can occur to the optic nerve, warranting surgical intervention. (2) The filtering bleb is considered to be the cornerstone of IOP control after glaucoma filtration surgery drainage device implantation. (3) It enables the flow of the aqueous humor from the anterior chamber to the subconjunctiva, episclera, sclera and choroid, thereby lowering the IOP. (4-6) Filtration and drainage devices, such as the EX-Press device (Alcon Laboratories, Fort Worth, Texas, USA), offer a surgical alternative to glaucoma medical therapy. (7) Open-angle glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level that the physician believes will prevent further glaucomatous damage. However, in a significant proportion of patients, the visual fields continue to deteriorate in spite of office pressures within the range of normal values (8). It has been suggested that the progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability not detected by tonometry during office hours. (9, 10) In another study, Asrani et al. (11) showed that IOP fluctuations are an independent risk factor in patients with glaucoma and as such may need to be treated specifically. It is possible that certain drugs or surgical interventions are more effective than others in dampening these fluctuations. The purpose of our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with medications or Ex-press filtration surgery.

Materials and Methods The study will include 20 open-angle glaucoma (OAG) patients underwent Ex-Press filtration surgery, and 20 OAG patients treated with medications alone. All patients will have 12 IOP measurements with 2 hours interval, starting at 10 AM until 10 AM of the following morning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Glaucoma patients that underwent EX-PRESS surgery

排除标准

  • Angle closure glaucoma
  • Neovascular glaucoma
  • High refractive error

结局指标

主要结局

Comparison of diurnal fluctuations of intraocular pressure

时间窗: One year

Comparison of diurnal fluctuations of intraocular pressure in glaucoma patients with and without EX-Press valve surgery

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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