Realtime, Dynamic, Intraocular Pressure during microaxial phacoemulsification using the Centurion Vision System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Surgical IOP (over the time period of the Quad portion of the surgical procedure ) measured as a peak to peak value
研究概览
简要总结
To measure Realtime, Dynamic, Intraocular Pressure during microaxial phacoemulsification using the Centurion Vision System and the Infiniti vision system
Prospective, Randomized, Clinical Study: Based on a peer-reviewed method. an IOP measuring sensor will be introduced through a 1.2mm paracentesis incision during the surgery. This will be connected to an IOP transducer, then received and amplified, then converted into digital signals (via Picoscope). A video mixer will then overlay the input from the laptop and from the surgical overlay, and will allow simultaneous visualization of real-time IOP, along with the parameters being used during surgery. Likewise, this same test will be done on the Alcon Infiniti system. Mean IOP values and peak-to-peak variations will be recorded Total patients: 40 maximum (20 per group)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification).
- •Only one eye of each patient will be included.
排除标准
- •Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract.
结局指标
主要结局
Surgical IOP (over the time period of the Quad portion of the surgical procedure ) measured as a peak to peak value
时间窗: Surgical IOP (over the time period of the Quad portion of the surgical procedure ) measured as a peak to peak value
次要结局
- Centurion Only -- Mean Surgical IOP (over the time period of the Quad portion of the surgical procedure ) – relative to IOP set point(2 months)