Comparison of Two Phacoemulsification-methods: HF EasyTip 2.2mm vs. HF EasyTip 2.8mm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- phacoemulsification time
研究概览
简要总结
The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral age-related cataract
- •good overall physical constitution
排除标准
- •previous intraocular surgery or ocular trauma
- •previous corneal pathology
- •previous endothelial cell count <1200
- •diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
- •intraocular complication like posterior capsular
- •postoperative comlpications (e.g. postoperative uveitis)
研究组 & 干预措施
HF easyTip 2.2mm
The phacoemulsifications tip used was the easyTip 2.2mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 45ml/min, vacuum 600 mmHg, bottle height 100cm.
干预措施: cataract surgery (Procedure)
HF easyTip 2.8mm
The phacoemulsifications tip used was the easyTip 2.8mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 50ml/min, vacuum 600 mmHg, bottle height 100cm.
干预措施: cataract surgery (Procedure)
结局指标
主要结局
phacoemulsification time
时间窗: intraoperative
time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it
effective phacoemulsification time
时间窗: intraoperative
time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)
fluid volume
时间窗: intraoperative
amount of BSS used for dividing and conquering
次要结局
- postoperative corneal oedema(1 day, 1 week, 6 months)
- postoperative endotheial cell loss(6 months)
研究者
Rupert Menapace
Ao.Univ.-Prof. Dr.med.univ.
Medical University of Vienna