SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 5
- 主要终点
- Number of observed pressure peaks (>30% of the patient-specific target pressure)
研究概览
简要总结
The SALUS project is developing a new form of care, the application of self-tonometry by the patient itself, and an accompanying electronic case file connecting clinics, doctor's offices and patients.
详细描述
The SALUS project is developing an outpatient, intersectoral form of care in which patients measure their intraocular pressure in their home environment with a so-called self-tonometer. The measured intraocular pressure values are incorporated into daily pressure profiles, which can be viewed via an electronic case file together with further examination data both by the treating ophthalmologists in the doctor's offices and clinics and by the patients. The new form of care not only supports the telemedical networking of doctors but also increases the compliance by involving the patient in the entire course of the illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Requirement of a stationary day and night measurement
- •Statutory health insurance
- •Verified and suspicion of glaucoma diagnosis with suspicion of pressure variations and peaks or not attained target pressure or suspicion of glaucoma progression (H40.1, H40.2 und H42.-)
- •Willingness for therapy in one of the participating clinics
- •Adequate German language skills
- •Signed and dated informed consent for study participation and data transfer
- •Legal capacity of the insurant to agree to the study participation
排除标准
- •Patients outside the catchment area of the participating clinics
- •Covering illnesses in psychiatry, neurology or other indications (e.g. impairment of independence) which make self-tonometry impossible
- •Strong communication barriers that do not allow the instruction to carry out the intervention
- •Unclear legal capacity of the potential study participants
结局指标
主要结局
Number of observed pressure peaks (>30% of the patient-specific target pressure)
时间窗: 7 days (outpatient) or minimum 24 hours (stationary)
Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.
次要结局
- Visual field index (VFI)(Baseline and after 9 and 12 months)
- Quality of life (patient-oriented)(Baseline and after 12 months)
- Number of sick pay days(12 month course)
- Pattern standard deviation (PSD)(Baseline and after 9 and 12 months)
- Rim volume(Baseline and after 12 months)
- Rim area(Baseline and after 12 months)
- Mean deviation (MD)(Baseline and after 9 and 12 months)
- Retinal nerve fiber layer thickness(Baseline and after 12 months)
- Number of inpatient and outpatient health services(12 month course)
- Costs of health services(12 month course)
- Number of periods of incapacity for work (unspecific and diagnosis-specific)(12 month course)
- Systolic and diastolic blood pressure(for 24 hours during outpatient and stationary measurements of intraocular pressure)
研究者
Nicole Eter
Chairholder and Head of the Department of Ophthalmology
University Hospital Muenster