Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Cumulative Dissipated Energy (CDE)
研究概览
简要总结
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.
详细描述
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes;
- •Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- •Calculated lens power within the available range;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any pathology that could reduce visual potential;
- •Hypotony or the presence of a corneal implant;
- •Residual, recurrent, active ocular or eyelid disease;
- •Poorly dilating pupil;
- •Any contraindication to cataract;
- •Eyes with two different levels of cataract grade;
- •Pregnant, or planned pregnancy during the study;
- •Expected to require an ocular surgical treatment at any time during the study;
- •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)
CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye.
次要结局
- Percentage of Average Torsional Amplitude(Day 0 (operative day))
- Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit(Preoperative, Day 150-210 (post-operative))