Cumulative Dissipated Energy (CDE) and Total Phacoemulsification Energy (Joules) of Unity VCS/CS With 4D Phaco Compared to Centurion System With OZil
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
- Cumulative Dissipated Energy
研究概览
简要总结
This clinical trial compares two phacoemulsification systems used in a bilateral cataract surgery subjects, in order to study CDE and Ultrasound time during cataract removal
详细描述
Unity and Centurion are two phacoemulsification systems routinely used during cataract surgery to assist the surgeon in removing the cataractous lens from the eye. This clinical trial aims to compare the performance of Unity versus Centurion during standard cataract surgery.
The primary objective of this study is to explore CDE and Ultrasound time during cataract extraction compared to Centurion.
This study will enroll 30 subjects (60 eyes) diagnosed with Nuclear Sclerosis cataract who require cataract surgery with intraocular lens implantation in both eyes.
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
- •Healthy patients 18 years or older undergoing uncomplicated sequential bilateral cataract surgery with phacoemulsification and IOL implantation
- •Expected to undergo sequential cataract surgery in both eyes
- •Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3 or above (see appendix III)
- •Both eyes will be operated on by the same surgeon
- •Have the ability to consent for study and procedure planned
排除标准
- •Patients under 18 years of age.
- •Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome, traumatic zonular weakness) that may require use of zonular support devices during surgery (e.g. capsular hooks) and/or implantation of capsular tension rings or other zonular support devices, and in the investigator's judgment, may interfere with the surgical procedure or study outcome measures.
- •Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)
- •Undergoing femtosecond laser-assisted lens fragmentation.
- •Surgical complications, in the opinion of the investigator, occurring either intraoperatively or postoperatively (including capsule tears, iris trauma, or decentered intraocular lens) and not attributable to the study device or study design.
- •Prior ocular surgery (including intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment, if it interferes with the outcome measures of this study.
- •Presence of endothelial cell dystrophies and/or corneal comorbidities.
- •History of intraocular inflammation (e.g., uveitis, iritis).
- •History of retinal edema or presence of a clinically significant epiretinal membrane that, in the investigator's clinical judgment, may interfere with the outcome measures of this study.
- •History of retinal surgery (e.g.retinal detachment repair, membrane peel) involving vitrectomy.
- •Dense brunescent cataract that in the investigator's clinical judgment, may interfere with the outcome measures of this study.
研究组 & 干预措施
Unity VCS/CS with 4D Phaco Handpiece
Patients are generally randomized to undergo surgery with Unity VCS/CS system with 4D phacoemulsification on one of there eyes
干预措施: Cataract extraction with phacoemulsification comparing two systems (Device)
Centurion vision system with OZil Handpiece
Patients are generally randomized to undergo surgery with Centurion system with OZil technology phacoemulsification on one of there eyes
干预措施: Cataract extraction with phacoemulsification comparing two systems (Device)
结局指标
主要结局
Cumulative Dissipated Energy
时间窗: Intraoperative
CDE is a measure of the total ultrasound energy delivered into the eye during phacoemulsification cataract surgery
次要结局
- Total Ultrasound Time(Intraoperative)
研究者
Nicole Fram M.D.
Principal investigator
Advanced Vision Care