Measurement and Logging of Posturing Adherence of Patients After Intraocular Surgery With Gasendotamponades Using a Sensorsystem With Different Feedback-Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Effective time of ideal posturing with different sensors-systems
研究概览
简要总结
Measuring and logging head positions of patients which underwent surgery with gasendotamponades.
详细描述
After surgery with gasendotamponades various positions are recommended to support the success of surgery. In patients with macular holes face-down-position is recommended. In patients with retinal detachment the recommended position depends on the region of the detachment.
The adherence of patients to follow this posturing instructions is very inhomogenous. Therefore the investigators want to measure the posturing by the use of a position-sensor. In some study arms the patients also receive a feedback from the sensor (tone, vibration) to correct the position.
The sensor-device was developed by the study-staff and is not commercial available. In addition there is no trade name. The patients safety of the used device was approved by the in house technical department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •age >18 years
- •full thickness macular hole or retinal detachment
- •informed consent
排除标准
- •intraoperative complications with the need of other endotamponades
- •combined treatment
结局指标
主要结局
Effective time of ideal posturing with different sensors-systems
时间窗: up to 12 month
Time (measured in minutes and in percent of 24h) with correct posturing in relation to the used sensor-type (with and without feedback)
次要结局
- Analysis of time with optimal posturing for both Sensor-Feedback-Systems(up to 12 month)
- Time analysis with optimal posturing after detailed explanation of posturing positions(up to 12 month)
- Tolerability of sensor-systems for patients as measured by questionnaire(up to 12 month)
- Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)(up to 12 month)