First-in-Human Robot-Assisted Subretinal Drug Delivery Under Local Anesthesia
First-in-Human Robot-Assisted Subretinal Drug Delivery Under Local Anesthesia
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DOI：
10.1016/j.ajo.2021.11.011
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发表时间：
2022-01-15
影响因子：
4.2
通讯作者：
MacLaren, Robert E.
中科院分区：
文献类型：
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作者：
Cehajic-Kapetanovic, Jasmina;Xue, Kanmin;MacLaren, Robert E.
目得：报告首次在人类研究的结果，使用机器人设备，以协助视网膜下药物输送的患者接受玻璃体视网膜手术黄斑hemorrhages.DESIGN：双臂，随机对照手术试验（ClinicalTrials.gov标识符：NCT 03052881）。方法：该研究是在牛津眼科医院，牛津大学医院NHS基金会信托，牛津大学，英国。根据预先规定的入选和排除标准，共招募了12名参与者-机器人辅助组6名，手动对照组6名。所有受试者均因继发于新生血管性年龄相关性黄斑变性的中心凹下出血而出现急性视力丧失。标准玻璃体切除术后，术中光学相干断层扫描引导下视网膜下注射组织型纤溶酶原激活剂（TPA），无论是机器人辅助或传统的手动技术进行局部麻醉。该程序的机器人部分涉及通过视网膜推进套管并在脚控注射高达100 μ L TPA溶液期间稳定它。我们评估了手术的成功，手术时间，不良事件，和耐受性的局部麻醉下的手术。结果：该程序是耐受性良好的所有参与者和安全地进行在所有情况下。两组之间的手术总持续时间、完成注射所需时间和视网膜微创伤相似，无临床意义。视网膜下出血成功地取代在1个月postintervention，除了1个对照组，和视力的中位数增益是相似的，在两个arms.CONCLUSIONS：这首次在人类研究表明，高精度robotassisted视网膜下药物输送的可行性和安全性的一部分，黄斑下出血的手术治疗，模拟其潜在的未来应用基因或细胞治疗。(C)2021爱思唯尔公司All rights reserved.
PURPOSE: To report the results of a first-in-human study using a robotic device to assist subretinal drug delivery in patients undergoing vitreoretinal surgery for macular hemorrhage.DESIGN: Double-armed, randomized controlled surgical trial (ClinicalTrials.gov identifier: NCT03052881).METHODS: The study was performed at the Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom. In total, 12 participants were recruited-6 in the robot-assisted and 6 in the control manual surgery arm according to the prespecified inclusion and exclusion criteria. All subjects presented with acute loss of vision owing to a subfoveal hemorrhage secondary to neovascular age-related macular degeneration. After standard vitrectomy, intraoperative optical coherence tomography-guided subretinal injection of tissue plasminogen activator (TPA) was performed by either robot-assisted or conventional manual technique under local anesthesia. The robotic part of the procedure involved advancement of a cannula through the retina and stabilizing it during foot-controlled injection of up to 100 mu L of TPA solution. We assessed surgical success, duration of surgery, adverse events, and tolerability of surgery under local anesthesia.RESULTS: The procedure was well tolerated by all participants and safely performed in all cases. Total duration of surgery, time taken to complete the injection, and retinal microtrauma were similar between the groups and not clinically significant. Subretinal hemorrhage was successfully displaced at 1 month postintervention, except for 1 control subject, and the median gain in visual acuity was similar in both arms.CONCLUSIONS: This first-in-human study demonstrates the feasibility and safety of high-precision robotassisted subretinal drug delivery as part of the surgical management of submacular hemorrhage, simulating its potential future application in gene or cell therapy. (C) 2021 Elsevier Inc. All rights reserved.