NCT01495299撤回不适用
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 24-h IOP patterns
研究概览
简要总结
The purpose of this study is to determine the relationship between intraocular pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to comply with the study procedures
- •18-80 years old
- •Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment.
- •Subject has consented to be in the trial
- •Visual acuity of 20/200 or better
- •Presence of cataract requiring phacoemulsification with lens exchange
- •Ability to understand the character and individual consequences of the study
- •For women of childbearing potential, adequate contraception
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •Subjects with contraindications for wearing contact lenses
- •Severe dry eye syndrome
- •Keratoconus or other corneal abnormality
- •Conjunctival or intraocular inflammation
- •Eye surgery prior to and throughout the study.
- •Full frame metal glasses during SENSIMED Triggerfish® monitoring
- •Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
- •Pregnancy and lactation
- •Simultaneous participation in other clinical studies
结局指标
主要结局
24-h IOP patterns
时间窗: 24 hour
次要结局
未报告次要终点
研究者
研究点 (1)
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