Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Duration of Core vitrectomy
研究概览
简要总结
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
详细描述
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
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 (Participant)
盲法说明
Patients are randomised and masked from the treatment
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
- •Patient over 18 years of age who are undergoing vitrectomy for the following conditions:
- •Macular hole
- •Epimacular membrane
- •Vitreous hemorrhage
- •Primary retinal detachment
排除标准
- •Patient who is
- •unable to give proper consent
- •previous vitrectomy or scleral buckle surgery
- •cases requiring silicone oil tamponed
- •undergoing repeated retinal detachment surgery
- •undergoing surgery for tractional diabetic retinopathy
结局指标
主要结局
Duration of Core vitrectomy
时间窗: intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)
Measurement of core vitrectomy duration by Constellation Vision System
次要结局
- Non-inferiority of intraoperative and postoperative complication(3 months)
研究者
Dr. Nicholas Fung
Clinical Asst Professor
The University of Hong Kong