IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- incidence of intra-operative adverse events that determine the safety of the surgery
研究概览
简要总结
To perform a safety study on the prototype IRIS vitrectomy device.
详细描述
to determine the safety and effectiveness of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients that are scheduled for vitrectomy surgery, regardless of the indication
- •Both vitrectomy-only and combined phaco-vitrectomy surgeries
- •Primary or repeat vitrectomy
- •General or local anesthesia, or combination
- •Informed consent (from parents in patients <18 years old)
排除标准
- •Unable to obtain informed consent from patient (or from parents in children)
- •No post-operative 8 week visit is anticipated
研究组 & 干预措施
IRIS vitrectomy device
all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device
干预措施: IRIS (Device)
结局指标
主要结局
incidence of intra-operative adverse events that determine the safety of the surgery
时间窗: Intraoperative (surgery day)
complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem
次要结局
未报告次要终点