Can Self-monitoring of the Intraocular Pressure With the Icare HOME Make Hospital-based Diurnal Monitoring Redundant?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
研究概览
简要总结
Glaucoma remains the leading cause of irreversible blindness worldwide. Glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field.
Elevated intraocular pressure remains the most important risk factor. Interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure.
Recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. In order to detect pressure peaks diurnal measurements are mandatory. Costly in-hospital diurnal measurements are the current standard.
The primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Subjects aged 18 and older
- •Glaucoma patients and healthy controls
- •Best corrected visual acuity >0.1
- •Astigmatism ≤ 3dpt.
- •Good compliance
- •Central corneal thickness (400-650μm)
- •Passed certification procedure (detailed description under: Measurements and procedures)
- •Therapeutic regimen unchanged throughout the past 30 days
排除标准
- •History of ocular trauma
- •Corneal condition interfering with tonometry (keratoconus, corneal scaring) Visual acuity <0.1
- •Physical or mental disability interfering with self-tonometry (e.g. arthritis, Parkinson's disease)
- •Dry eye disease
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
icare HOME
干预措施: icare HOME device (Icare Oy, Vanda, Finland) (Device)
结局指标
主要结局
Comparison of an in- hospital diurnal pressure pattern of intraocular pressure to the pattern derived from self-tonometry using icare HOME in an outpatient setting.
时间窗: 4 years
Statistical methods for analysis of continuous method comparison data will be applied. The primary goal is to quantify the extent of agreement between two methods (Intraocular pressure measurement in-hospital and at home) and determine whether they sufficiently agree to be used interchangeably.
次要结局
- variance of diurnal intraocular pressure(4 years)
- Influence of daily activities(4 years)
- Change of treatment(4 years)