A Novel Device for Ultra-Rapid Non-Pharmacologic Ocular Anesthesia

一种用于超快速非药物眼部麻醉的新型装置

• 批准号: 9883617
• 负责人: Thomas W Chalberg
• 金额: $ 24.72万
• 依托单位: IRENIX MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9883617
• 关键词: Achievement; Address; Adverse effects; Analgesics; Anesthesia procedures; Anesthetics; Animals; Blurred vision; Body Weight decreased; Clinical; Clinical Trials; Custom; Data; Device Safety; Device or Instrument Development; Devices; Diffusion; Drug Delivery Systems; Enrollment; Eye; FDA approved; Feasibility Studies; Food and Drug Administration Device Approval; Formulation; Gel; Health Services Accessibility; Hour; Human; Injection of therapeutic agent; Injections; Interview; Lidocaine; Macular degeneration; Medical; Medicine; Nerve Endings; Neural Conduction; Oryctolagus cuniculus; Outcome; Pain; Pain management; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Physicians; Pilot Projects; Procedures; Production; Randomized; Records; Reporting; Retina; Retinal Diseases; Retinal Vein Occlusion; Safety; Site; Specialist; Study Subject; Subconjunctival Hemorrhage; System; Technology; Temperature; Testing; Time; Tissues; Toxic effect; United States; Vascular Endothelial Growth Factors; Vision; Visual Acuity; Work; arm; base; cold temperature; commercialization; corneal epithelium; design; diabetic; ergonomics; experience; feasibility trial; first-in-human; human data; human subject; improved; intravitreal injection; macular edema; novel; ocular surface; oral pain; patient safety; pre-clinical; preservation; prototype; research clinical testing; safety testing; satisfaction; side effect; standard of care; success

PROJECT SUMMARY / ABSTRACT The objective of this Phase II proposal is to further develop a novel device for ocular anesthesia based on thermo-electric cooling. Intravitreal injection therapy (IVT) is one of the most commonly performed procedures in all of medicine, with approximately 7 million injections in the USA in 2016. Ocular anesthesia is required, both for patient safety and for tolerability of these vision-preserving injections. To date, all local ocular anesthetics are lidocaine based and function via diffusion of this medication through ocular tissues. Drug diffusion into deeper ocular layers and nerve endings takes between 5-10 minutes and is associated with corneal epithelial toxicity, resulting in post-injection pain and blurred vision. To address the limitations of currently available ocular anesthesia, we have created a device that uses precisely-regulated cold temperatures to deliver focal, ultra-rapid, non-pharmacologic anesthesia to the ocular surface immediately before IVT administration. Pre-clinical device safety testing did not show any evidence of toxicity in rabbits. In addition, our early feasibility study demonstrated proof-of-concept and confirmed safety in humans, with effective anesthesia and no toxicity in study subjects. In this proposal, we aim to further optimize temperature and time point settings of our novel focal anesthesia by thermo-electric cooling (FAnTEC) device in an expanded phase II feasibility study. Data obtained from this trial will be used to design the commercial-ready prototype with a simplified user interface, and this device will be tested in a pivotal phase III clinical trial to support FDA device approval. If successful, this project will lay the groundwork for device manufacturing and commercialization of the FAnTEC device, improving the IVT experience for millions of patients receiving IVT in the United States and around the world. !

项目摘要/摘要