Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Cumulative Dissipated Energy
研究概览
简要总结
The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
- •Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
- •Willing to undergo second eye surgery within 14 days of first eye surgery;
- •Willing and able to understand/sign a written Informed Consent Document;
- •Willing and able to return for scheduled follow-up examinations;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
- •Previous intraocular or corneal surgery of any kind;
- •Poorly dilating pupil;
- •Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
- •Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
- •Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;
- •Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
- •Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
CENTURION
First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
干预措施: CENTURION® Vision System (CVS) (Device)
CENTURION
First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
干预措施: INFINITI® Vision System (IVS) (Device)
INFINITI
First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
干预措施: CENTURION® Vision System (CVS) (Device)
INFINITI
First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
干预措施: INFINITI® Vision System (IVS) (Device)
结局指标
主要结局
Cumulative Dissipated Energy
时间窗: Day 0 (operative day), each eye
Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.
Aspiration (ASP) Fluid Used
时间窗: Day 0 (operative day), each eye
Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.
次要结局
- Aspiration Time(Day 0 (operative day), each eye)