NCT01028664已完成不适用
Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox
Sensimed AG2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Detection of IOP reduction 2 hours after Diamox administration
研究概览
简要总结
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of glaucoma or ocular hypertension
- •IOP of ≥ 15 mmHg.
- •Patients of either gender.
- •Older than 18 years.
- •Patients who accept signing an informed consent approved by the Ethics Committee.
排除标准
- •Patients not able to understand the nature of the research
- •Patients under tutorship
- •Corneal abnormalities in both eyes
- •Subjects with contraindications for wearing contact lenses
- •History of ocular surgery within the last 3 months
- •Known hypersensitivity to Diamox® or to any of its excipients
- •Pregnancy and lactation
- •Simultaneous participation in other clinical research
- •Patients with evidence of ocular infection or inflammation
- •History of renal or hepatic impairment, hypokalemia and hyponatremia
结局指标
主要结局
Detection of IOP reduction 2 hours after Diamox administration
时间窗: 2 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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