Home Tonometry for Monitoring Glaucoma:a Pilot Study of the Icare Home Tonometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.
详细描述
Monitoring of glaucoma requires frequent evaluation of IOP and disease severity, typically with visual field tests. When a patient is diagnosed with glaucoma an optimum level of IOP (or target IOP) is determined based on patient's characteristics, such as severity of disease and life expectancy. In current models of care patients have their IOP measured at the clinic at different intervals. If the IOP is noted to be high, or above the patient's target, additional treatment is recommended. Accurate and frequent IOP measurements at different points in time are thus imperative.
Tonometry is usually conducted by clinicians in an eye clinic. Some tonometers (e.g., Icare) have the potential to be used by the individual for home monitoring of IOP for patients with suspected glaucoma/glaucoma. Self-monitoring of IOP via home tonometry will allow patients to undergo IOP measurements at different points in time (e.g., early morning and night-time, and it can help determine diurnal changes and spikes).
The overall objective of the current study is to conduct a feasibility pilot study on the home tonometer (Icare), acquiring initial experience with the Icare tonometer. For this purpose investigators will train up to 20 individuals on how to use the device. Investigators will ask them to record in a diary their IOP twice a day for a period of 2 weeks. Investigators will then compare IOP outcomes with the measurement taken at the clinic. Patients and clinicians will be masked to the IOP data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
- •Aged 18 years or over
- •Patient deemed able to monitor their IOP at home (by themselves or a helper)
排除标准
- •Not receiving IOP monitoring (for glaucoma or ocular hypertension)
- •Aged <18 years
- •Patients deemed unable to monitor their IOP at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer
- •Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
- •Patient has preexisting corneal disease
结局指标
主要结局
Intraocular Pressure
时间窗: Two weeks
Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.
次要结局
- Proportion of Patients With an Adverse Event(One month)
- Proportion of Patients Able and Willing to Use the Tonometer(Two weeks)
研究者
Professor Augusto Azuara-Blanco
Professor
Queen's University, Belfast