Robotic Subretinal tPA Injection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients with succesful subretinal insertion of the robot-held 41G needle
研究概览
简要总结
In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:
- The robotic stabilizer (prototype - FAMHP approval received)
- 41G subretinal needle (CE marked - used within label)
- Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.
As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.
详细描述
Age-related macular degeneration is a common disease in the elderly population. In the atrophic form, central retinal degeneration leads to the formation of central metamorphopsia or scotoma. In 10% of all cases, the atrophic form becomes proliferative, whereby newly formed vessels grow under the macular area. Although this proliferation can be controlled in most patients with intravitreal injections of anti-VEGF, in some cases a subretinal hemorrhage occurs which causes a drastic drop in visual acuity.
Before anti-VEGF treatment existed, removal of the subretinal vessels followed by a macular translocation or transplantation of retinal pigment epithelium cells was sometimes considered in such cases when the second eye became affected 1,2.
Later on, when anti-VEGF and other growth inhibiting products became available (Macugen, Lucentis, Avastin, Eylea, BeoVue), ophthalmologistsdeveloped a far less invasive surgically technique to inject tPA subretinally into the blood clot using a 41G (0.11mm) subretinal needle, followed by an air fill of the vitreous cavity to displace the subretinal liquefied blood away from the macular area 3,4.
Since the causal neovascular vessels are not removed during this procedure, repeat injections with anti-VEGF or analogue products are mandatory afterwards to reduce the risk of recurring hemorrhage.
This surgical technique typically consists of a standard three-port pars plana vitrectomy, induction of posterior vitreous detachment (if not already present), core and peripheral vitrectomy (EVA Nexus surgical system, DORC, Zuidland The Netherlands). Macular detachment is induced by subretinal injection of a balanced salt solution (BSS). The injection device is a 41G polyimide straight subretinal cannula with 27G shaft (DORC) connected to the Inicio micro-injection system (DORC). The EVA Nexus surgical system, the 41G subretinal needle and the Inicio micro-injection system used in this study are all CE-labeled devices and used on-label.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Patients that are scheduled for vitrectomy surgery to treat a submacular hemorrhage with subretinal injection of tPA.
- •Both vitrectomy-only and combined phaco-vitrectomy surgeries
- •General anesthesia
排除标准
- •Patients aged < 18 years
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study protocol.
- •Vitrectomy surgery for other indication than mentioned above
- •No post-operative week 8 visit is anticipated
- •General anesthesia not possible
研究组 & 干预措施
Robotic subretinal tPA injection group
The purpose of this study is to determine the feasibility of subretinal injection of tPA assisted by a prototype robotic device.
干预措施: Robotic subretinal tPA injection (Device)
结局指标
主要结局
Percentage of patients with succesful subretinal insertion of the robot-held 41G needle
时间窗: During surgery, once vitrectomy is completed, pass/fail event.
The insertion of a 41G subretinal needle adjacent to a subretinal hemorrhage using the stabilizing (tremor-reducing) properties of a robotic instrument will be evaluated. Succesful formation of a subretinal bleb will prove that the needle was introduced subretinally. This will be monitored visually through the operating microscope and with intra-operative OCT confirming the bleb formation.
Percentage of patients with stable subretinal position of the needle for at least 3 minutes.
时间窗: During surgery, immediately after insertion of the needle in the subretinal space for up to 3 minutes.
The ability to hold the needle still in the subretinal space for a time of up to 3 minutes after initiating bleb formation will be determined.This will be monitored visually through the operating microscope and with intra-operative OCT confirming the stable position of the needle.
次要结局
- Device-related adverse events(Duration of surgery: +/- 90 minutes)
- Functional outcome(2 months post-operative)