NCT05868772已完成不适用
What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
Cataract and Laser Institute of Southern Oregon1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total Aspiration Time
研究概览
简要总结
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.
详细描述
This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
- •Undergo uneventful cataract surgery.
- •Gender: Males and Females.
- •Both eyes must have same grade of cataract.
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and other study procedures.
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Patient under 50 years of age.
- •Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
- •Patient cataract surgery complicated by posterior capsular tear.
- •Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, RA, prior refractive surgery, etc).
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Total Aspiration Time
时间窗: Day of surgery (Day 0)
次要结局
- Central Corneal Thickness(1 week postoperative)
- Total Fluid Volume(Day of surgery (Day 0))
- Total Phaco Time(Day of surgery (Day 0))
研究者
研究点 (1)
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