Comparison of Ultrasound Efficiency and Early Postoperative Outcomes of Two Phacoemulsification Systems (UNITY VCS 4D Phaco and Centurion With Active Sentry Probe): A Randomized Contralateral Eye Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
研究概览
简要总结
This prospective, randomized, contralateral (crossover) study compares the ultrasound efficiency and early postoperative outcomes (Day 1 and Day 7) of two phacoemulsification platforms - the UNITY® VCS system with 4D Phaco and the Centurion® Vision System with ACTIVE SENTRY® Handpiece - used in the two eyes of the same patient undergoing cataract surgery.
详细描述
Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade) will have one eye randomized to the UNITY VCS system and the contralateral eye to the Centurion Vision System, with the same surgeon and using the same low IOP fluidics parameters. The contralateral eye surgery will be performed two weeks after the first eye surgery. The study will evaluate ultrasound efficiency using machine-recorded parameters, best-corrected visual acuity (BCVA), and central corneal thickness (CCT) on postoperative Days 1 and 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for uncomplicated phacoemulsification with comparable cataract density between eyes (within one LOCS III grade)
排除标准
- •Prior corneal or intraocular surgery
- •Significant corneal pathology
- •Significant asymmetry between eyes in: cataract density, astigmatism, or axial length
研究组 & 干预措施
UNITY VCS SYSTEM ®
干预措施: CENTURION VISION SYSTEM ® (Device)
CENTURION VISION SYSTEM ®
干预措施: UNITY VCS SYSTEM ® (Device)
结局指标
主要结局
Ultrasound efficiency evaluated through Cumulative Dissipated Energy (CDE) required to remove the cataract
时间窗: Intraoperative
次要结局
- Ultrasound efficiency evaluated through Ultrasound (U/S) Total Time(Intraoperative)
- Ultrasound efficiency evaluated through Total Aspiration Time(Intraoperative)
- Ultrasound efficiency evaluated through Estimated Fluid Aspirated(Intraoperative)
- Ultrasound efficiency evaluated through Total Case Time(Intraoperative)
- Best-corrected visual acuity (BCVA)(Postoperative Day 1 and Day 7)
- Central corneal thickness (CCT)(Postoperative Day 1 and Day 7)
研究者
Biljana Kuzmanović Elabjer
Prof.
University Hospital Sveti Duh