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

开发首个安全有效的前房穿刺器械来治疗和诊断眼部疾病

• 批准号: 10697928
• 负责人: samer farah
• 金额: $ 90.59万
• 依托单位: F SQUARE MEDICAL LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697928
• 关键词: Acute; Address; Adult; Advanced Development; Age related macular degeneration; American; Angle-Closure Glaucoma; Aqueous Humor; Biological Markers; Blindness; Caring; Cataract; Chronic; Ciliary Body; Clinical; Collaborations; Consensus; Cornea; Corneal Endothelium; Data; Development; Development Plans; Device or Instrument Development; Devices; Diabetic Retinopathy; Diagnosis; Diagnostic Procedure; Disease; Drug Monitoring; Economic Burden; Endophthalmitis; Evaluation; Exudative age-related macular degeneration; Eye; Eye Injuries; Eye diseases; Family suidae; Feedback; Freezing; Generations; Glaucoma; Goals; Hand; Hyphema; Iatrogenesis; Injury; Intervention; Iris; Legal patent; Liquid substance; Lymphoma; Medical; Medical Device; Methods; Modeling; Modernization; Monitor; Needles; Ophthalmologist; Ophthalmology; Output; Paracentesis; Participant; Patient Care; Patient-Focused Outcomes; Patients; Performance; Persons; Phase; Physiologic Intraocular Pressure; Positioning Attribute; Procedures; Production; Questionnaires; Readiness; Reproducibility; Retinal Detachment; Retinal Vein Occlusion; Retinoblastoma; Risk; Risk Reduction; Safety; Sampling; Selection for Treatments; Sterility; Structure; Surgeon; Syringes; Techniques; Trauma; Tuberculin; Uveitis; Vascular Endothelial Growth Factors; Vision; anterior chamber; aqueous; aspirate; commercialization; design; design verification; diagnostic biomarker; disability; disease diagnostic; experience; improved; individualized medicine; innovation; instrument; intravitreal injection; lens; manufacture; manufacturing run; meetings; phase 1 study; predictive marker; programs; prototype; standard of care; success; tool; usability

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.

项目摘要 尽管治疗眼部疾病，但威胁性疾病或眼损伤仍然是前10名 成年人的残疾。这些眼部条件中有几个需要前腔室可肠分析（ACP）。 ACP在临床上表示会降低急性升高的眼内压（IOP），以避免永久视力的风险 损失并为疾病诊断和监测采样水性幽默。需要减少IOP的条件 包括急性角度闭合青光眼，气动视网膜以治疗视网膜脱离和医源性IOP 与玻璃体内注射抗血管内皮生长因子（抗VEGF）剂的升高 治疗诸如新血管相关的黄斑变性，糖尿病性视网膜病和视网膜静脉等疾病 闭塞。需要水性幽默采样的条件包括内脑炎，葡萄膜炎，视网膜细胞瘤和 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 反VEGF代理。不幸的是，没有专门为ACP设计的仪器，而是 使用标准的超长针和有限的操作控制的结核蛋白注射器。这需要 当患者放置在缝隙灯生物显微镜中时，外科医生的手和稳定的患者眼睛，并且 通常需要助手。结果，ACP程序可能导致严重的并发症，例如菌丝 和白内障是由于对眼内结构（例如角膜，睫状体，虹膜和镜头）而引起的造成伤害 抽吸率和水容量难以控制和不可预测。不幸的是，没有 上个世纪ACP的安全性或效率的提高。克服与 现有的过时技术F Square Medical正在开发和商业化Parasafe™，这是有史以来的第一个 专为ACP程序设计的仪器。 Parasafe仪器是无菌的，一次性的，并且 重要的是，可控制，快速和可再现的ACP的安全仪器，而无需缝灯或 助手。通过完成成功的I阶段项目，F Square Medical构建了功能性alpha 原型并评估了其性能和可用性，以告知Beta原型细化。这个二期计划 将建立在实质I阶段数据包的基础上，并将重点放在编码I阶段的反馈上 最终用户数据以完善和锁定制造的帕拉皮武装设计，并在完整的阵列上执行 每21 CFR 820.30所需的设计控制活动，以将Parasafe推向FDA监管510（k） 提交，批准和可扩展生产。拟议的II期项目的完成将导致 向FDA提交510（k）的法规提交，以备Parasafe，该工具有可能显着 降低风险并扩大ACP的效用，从而将这种转型工具推向 商业化和改善患者护理。