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

项目摘要 尽管眼科疾病的治疗取得了进展，但威胁视力的疾病或眼损伤仍然是前10名 成年人的残疾。这些眼部疾病中的一些需要前房穿刺术（ACP）。 ACP在临床上适用于降低急性升高的眼内压（IOP），以避免永久视力的风险 损失，并对用于疾病诊断和监测的房水进行采样。需要降低IOP的疾病 包括急性闭角型青光眼、治疗视网膜脱离充气视网膜固定术和医源性IOP 与玻璃体内注射抗血管内皮生长因子（抗VEGF）药物相关的升高， 治疗新生血管性年龄相关性黄斑变性、糖尿病视网膜病变和视网膜静脉等疾病 闭塞。需要房水取样的病症包括眼内炎、葡萄膜炎、视网膜母细胞瘤和视网膜母细胞瘤。 淋巴瘤和水性生物标志物越来越多地指导治疗选择和药物监测，例如，与 抗VEGF剂。不幸的是，没有专门为非加太设计的文书， 使用具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 当患者位于裂隙灯生物显微镜中时，稳定的外科医生手和稳定的患者眼睛，以及 通常需要一个助手。因此，ACP手术可能导致严重的并发症，如前房出血 以及由于眼内结构的意外创伤而引起的白内障（例如，角膜、睫状体、虹膜和透镜）， 抽吸速率和水体积难以控制且不可预测。不幸的是， 在过去世纪，机场核心计划的安全或效率有所改善。为了克服与 现有的过时技术，F广场医疗正在开发和商业化Parasafe™，有史以来第一个 专为ACP手术设计的工具。Parasafe仪器是一种无菌、一次性和 重要的是，用于受控、快速和可再现ACP的安全仪器不需要裂隙灯或显微镜， 助手通过成功完成第一阶段项目，F Square Medical构建了功能性alpha 原型，并评估其性能和可用性，以告知beta原型的改进。第二阶段计划 将建立在第一阶段的大量数据包的基础上，并将重点放在整合第一阶段的反馈上 最终用户数据，以完善和锁定Parasafe设计，用于制造，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，将Parasafe推进至FDA监管510（k） 提交、批准和可扩展的生产。拟议的第二阶段项目完成后， 向FDA提交Parasafe的510（k）监管申请，Parasafe是一种有可能显著提高 降低风险并扩大ACP的效用，从而推动这一转型工具， 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.