Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases

项目总结 尽管眼科疾病的治疗取得了进展，但威胁视力的疾病或眼睛损伤仍位居前十 成年人中的残疾。其中一些眼部疾病需要前房穿刺术(ACP)。 ACP的临床应用表明可以降低急性升高的眼压，以避免永久视力的风险。 并采集房水样本，用于疾病诊断和监测。需要降低眼压的情况 包括急性闭角型青光眼、气动视网膜固定术治疗视网膜脱离以及医源性眼压 玻璃体内注射抗血管内皮生长因子(抗血管内皮生长因子)药物引起的眼球抬高 治疗新生血管性老年性黄斑变性、糖尿病视网膜病变和视网膜静脉疾病 闭塞。需要进行房水采样的情况包括眼内炎、葡萄膜炎、视网膜母细胞瘤和 淋巴瘤和含水生物标记物越来越多地指导治疗选择和药物监测，例如 抗血管内皮生长因子药物。不幸的是，没有专门为ACP设计的工具，而是 使用带有标准超长针头和有限操作控制的结核菌素注射器。这需要 当患者在裂隙灯生物显微镜中定位时，外科医生的手和患者的眼睛保持稳定，以及 通常需要一个助手。因此，ACP手术可能会导致严重的并发症，如前房出血。 由于眼内结构(如角膜、睫状体、虹膜和晶状体)意外损伤而导致的白内障，以及 吸液率和含液量是难以控制和不可预测的。不幸的是，一直没有 在过去的一个世纪中，机场核心计划的安全性或效率得到了改善。要克服与以下各项相关的限制 现有的过时技术，F Square Medical正在开发并商业化Parasafe™，这是有史以来第一次 专门为ACP程序设计的仪器。Parasafe仪器是一种无菌、一次性和 重要的是，用于受控、快速和可重现的ACP的安全仪器不需要裂隙灯或 助理。通过一个成功的第一阶段项目的完成，F Square Medical建立了一个功能性阿尔法 原型，并评估其性能和可用性，以通知测试版原型改进。此第二阶段计划 将以第一阶段的实质性数据包为基础，并将重点纳入第一阶段的反馈 最终用户数据，以改进和锁定Parasafe设计以供制造，以及在整个阵列上执行 根据21 CFR 820.30要求的设计控制活动，以使Parasafe符合FDA法规510(K) 提交、审批和可扩展生产。拟议的第二期项目完成后，将产生 向FDA提交关于Parasafe的510(K)监管文件，这一工具有可能显著 降低风险并扩大ACP的用途，从而推动这一变革性工具走向 商业化和改善病人护理。

PROJECT SUMMARY Despite advances in the treatment of ocular diseases, vision-threatening disease or eye injury remain the top 10 disabilities among adults. Several of these ocular conditions require an anterior chamber paracentesis (ACP). ACP is clinically indicated to reduce acutely elevated intraocular pressure (IOP) to avoid risk of permanent vision loss and to sample aqueous humor for disease diagnostics and monitoring. Conditions requiring IOP reduction include acute angle closure glaucoma, pneumatic retinopexy to treat retinal detachments, and iatrogenic IOP elevations associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents to treat diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal vein occlusions. Conditions requiring aqueous humor sampling include endophthalmitis, uveitis, retinoblastoma and lymphoma, and aqueous biomarkers increasingly are guiding treatment selection and drug monitoring, e.g., with anti-VEGF agents. Unfortunately, there exists no instrument specifically designed for ACP, and instead tuberculin syringes with standard excessively long needles and limited operational control are used. This requires a steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope, and often requires an assistant. As a result, the ACP procedure may lead to serious complications, such as hyphema and cataract due to inadvertent trauma to intraocular structures (e.g., cornea, ciliary body, iris and lens), and the aspiration rate and aqueous volume are difficult to control and unpredictable. Unfortunately, there have been no improvements in the safety or efficiency of ACP in the past century. To overcome the limitations associated with existing antiquated techniques, F Square Medical is developing and commercializing Parasafe™, the first-ever instrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable and importantly, safe instrument for controlled, rapid, and reproducible ACP without requiring a slit lamp or an assistant. Through the completion of a successful Phase I project, F Square Medical built a functional alpha prototype and assessed its performance and usability to inform beta prototype refinement. This Phase II program will build upon the substantial Phase I data package and will focus on incorporating feedback from the Phase I end-user data to refine and lock the Parasafe design for manufacture, as well as execute on the complete array of required design control activities per 21 CFR 820.30 to advance Parasafe to FDA regulatory 510(k) submission, approval, and scalable production. The completion of the proposed Phase II project will result in the filing of a 510(k) regulatory submission to the FDA for Parasafe, an instrument with the potential to significantly reduce the risk and expand the utility of ACP, thereby advancing this transformational instrument toward commercialization and improving patient care.