Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 主要终点
- Cumulative Dissipated Energy (CDE)
研究概览
简要总结
The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities classification system II (LOCSII)].
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to consent for participation;
- •Willing and able to attend postoperative examinations per protocol schedule;
- •Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
- •Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
- •Untreated or uncontrolled Glaucoma;
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
- •Poorly dilating pupil or other pupil defect;
- •Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);
- •Severe retinal disorders;
- •Corneal disease or retinal detachment;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Cumulative Dissipated Energy (CDE)
时间窗: Day 0 (operative day)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.
次要结局
- Cumulative Dissipated Energy (CDE)(Day 0 (operative day))
- Balanced Salt Solution (BSS) Fluid Used(Day 0 (operative day))