Registry of PHAcoemulsification for Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Description of intraoperative parameters during cataract surgery when using Active Sentry
研究概览
简要总结
Cataracts cause vision loss due to opacities in the lens. Cataract surgery is performed by emulsifying the nucleus of the lens. A phacoemulsifier is the machine used to deliver ultrasonic energy in the eye to fragment the lens and aspirate the debris.
In contrast to the large number of cataract procedures performed worldwide, there is surprisingly scarce data regarding the intraoperative parameters used during phacoemulsification. As new technologies are made available to surgeons, this impedes a large-scale analysis of the benefits of the advances in phacoemulsifiers. The investigators aim to establish a nationwide registry with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifier.
The data collected would encompass all parameters recorded in the phacoemusifiers' logs, such as the energy delivered in the eye (longitudinal, torsional and other), US time, BSS volume, duration of the procedure, surgeon settings and others. The objective will be to capture data from at least 100,000 procedures/year.
详细描述
A nationwide registry will be established with a database of intraoperative data recorded during the cataract procedures performed with the Centurion phacoemulsifiers. The following intraoperative parameters used during the cataract surgery will be recorded and analyzed:
Primary endpoint: Ultrasound time (US time)
Exploratory endpoints:
- CDE : Cumulated dissipated Energy
- Total surgery time
- BBS volume
- Torsional and longitudinal energy
- IOP settings
- Vacuum settings Procedures performed with the Active Sentry module - where a pressure sensor is built in the phacoemulsifier handpiece will be compared to other to procedures performed without this module.
Data will be collected and analyzed from Centurions cases log extracted from at least 200 Centurions installed in France. Parameter and settings will be retrospectively analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All procedures recorded in Centurions (200 machines).
排除标准
- •Opposition of the center to data collection.
- •Complicated surgery (e.g. anterior vitrectomy) identified as such in the event log
结局指标
主要结局
Description of intraoperative parameters during cataract surgery when using Active Sentry
时间窗: time of the surgery
To describe intraoperative parameters during cataract surgery when using Active Sentry compared with other handpieces in a large registry comprising at least 200 centurions (\>85 benefiting from the Active Sentry upgrade). Data will be collected and analyzed from event logs extracted from 200 Centurions installed in France. Parameters and settings will be analyzed retrospectively.
次要结局
未报告次要终点