Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Vitrectomy time
研究概览
简要总结
As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared
详细描述
Purpose:
This study aims to compare the performance of the Alcon 25+® UltraVit® 5000 cpm vitrectomy probe versus the 25+® Ultravit 10,000 cpm® beveled tip, dual drive vitrectomy probe. The safety profile and efficiency were compared.
Method:
Prospective, randomised study. Consecutive patients from January 2019 to August 2019 requiring vitrectomy for retinal detachment, epiretinal membrane, vitreous haemorrhage, and macula hole were randomized into either the 10K or 5K vitrectomy group. Both groups underwent vitrectomy using the proportional vacuum mode with the cut rate set at the fastest rate. Patients with previous vitrectomy, other ocular diseases (glaucoma, corneal disease, or significant corneal opacities), or trauma were excluded from the study. The primary endpoint was vitrectomy time, while secondary endpoints included posterior vitreous detachment time, intraoperative complications, and number of instruments used. The preoperative, postoperative 1 month and 3 month best corrected visual acuity (BCVA), and complications were recorded.
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
- Double (Participant, Care Provider)
盲法说明
Patients and Care provider are not able to differentiate the two different cutters since the port size are the exact same for both.
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
- •Consecutive patients over the age of 18 requiring vitrectomy for vitreous haemorrhage (VH), epiretinal membrane (ERM), macular hole (MH), dislocated lens, rhegmatogenous retinal detachment and diabetic tractional retinal detachment were randomized into the study from January 2019 till August 2019
排除标准
- •Patients with ocular comorbidities affecting surgical view including corneal opacities or scar, previous vitrectomy, history of trauma or requiring silicone oil were excluded from the study
研究组 & 干预措施
10k 25G cutter
New cutter, with a 10,000 cut per minute blade
干预措施: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter (Device)
5k 25G cutter
Traditional cutter, with a 5,000 cut per minute blade
干预措施: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter (Device)
结局指标
主要结局
Vitrectomy time
时间窗: 1 day
The time needed to remove all vitreous
次要结局
- Safety and complications(up to 6 months)
- Number of instruments used(1 Day)