Handheld Ocular Flare Meter Clinical Study

手持式眼眩光计临床研究

• 批准号: 8314785
• 负责人: Naresh Menon
• 金额: $ 15.55万
• 依托单位: CHROMOLOGIC, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-05 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314785
• 关键词: 20 year old; Affect; Animal Model; Animal Testing; Animals; Aqueous Flare; Aqueous Humor; Biological; Biological Assay; Blindness; Blood; Brain; Cells; Chronic Childhood Arthritis; Clinical; Clinical Data; Clinical Research; Computer software; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Disabled Persons; Disease; Doctor of Philosophy; Early Diagnosis; Environment; Equipment; Evaluation; Extravasation; Eye; FDA approved; Flare; Generations; Goals; Government; Hand; Health; Human; In Vitro; Individual; Inflammation; Lasers; Lead; Marketing; Masks; Measurement; Measures; Methods; Microscope; Monitor; Ophthalmic examination and evaluation; Ophthalmology; Ophthalmoscopy; Optical Instrument; Optics; Organ; Outcome; Patients; Performance; Persons; Phase; Process; Proteins; Radiation; Research; Research Contracts; Research Personnel; Resources; Sensitivity and Specificity; Severities; Solutions; Staging; Technology; Testing; Time; United States; Universities; Uveitis; Validation; Vision; Visual; Visual Acuity; Washington; Western World; Work; anterior chamber; clinical Diagnosis; clinically relevant; computerized data processing; cost effective; design; disease diagnosis; experience; handicapping condition; in vivo; innovation; instrument; instrumentation; light scattering; meter; novel; preclinical study; prevent; programs; prototype; research clinical testing; standard measure; success

DESCRIPTION (provided by applicant): Although there are ~300,000 to 600,000 individuals in the United States with active uveitis, there is no clinically accepted method for quantitative assessment of ocular flare that would result in rapid, non-invasive diagnosis of uveitis. Current methods of diagnosis for uveitis involve a thorough examination of the eye with a slit lamp microscope and ophthalmoscopy. Higher levels of flare in particular have been associated with poor visual outcomes in patients with certain forms of uveitis, such as uveitis associated with juvenile arthritis (Holland & Stiehm 2003)(Rosenberg et al. 2004). These tests are both time intensive and largely subjective (Kempen et al. 2008). The only FDA approved device that currently is able to provide an objective assessment of the degree of uveitis is the KOWA laser flare meter (FM-600); this is a bench top device and is not suitable for cost effective for widespread field use. To overcome this major health need, ChromoLogic LLC (CL), will develop and validate a handheld Ocular Flare meter (OFAM) - a non-invasive instrument platform that has shown promise in diagnosing disease and radiation induced blood eye barrier disruption in less than 1minute. Preliminary in vitro and pilot clinical data obtained with an early generation prototype has demonstrated the efficacy of the technology. The results also show initial sensitivities that far exceed (100X) the commercially available bench top KOWA product. During Phase I of the proposed project, CL will further optimize the OFAM technology and demonstrate its sensitivity and specificity through staged animal and clinical studies. The results from Phase will be used towards an FDA IDE filing. PUBLIC HEALTH RELEVANCE: The mammalian eye, like the brain, is considered an immunologically privileged organ because it includes multiple mechanisms that stave of inflammation. This is a biological necessity developed to preserve visual acuity. As a result, any inflammation to the eye, known as uveitis affects vision and sometimes, permanently damages it. At any given time, there are approximately 300,000 to 600,000 individuals in the United States that have active uveitis. Approximately 10% of visual handicaps in the western world and up to 15% of all cases of total blindness in the United States is attributed to uveitis. The key to managing active uveitis and preventing deleterious effects resulting form it is timely actionable diagnosis. Current methods of diagnosis for uveitis involve a thorough examination of the eye with a slit lamp microscope and ophthalmoscopy - resulting in a subjective score known as ocular flare. Higher levels of flare in particular have been associated with poor visual outcomes in patients with certain forms of uveitis, such as uveitis associated with juvenile arthritis. Thes tests are both time intensive and largely subjective. The only device that currently is able to provide an objective assessment of the degree of uveitis in the KOWA laser flare meter (FM-600); this is a bench top device that is neither cost effective nor has the sensitivity to diagnose early stages of uveitis. As a result, this 20+ year old technology is not being used for clinical diagnosis today. Given the severity and scale of deleterious outcomes that could result from uveitis and the lack of an objective method to diagnose the condition and monitor any therapies administered, there is an urgent need for a rapid, portable and highly sensitive diagnostic solution.

描述（由申请人提供）：尽管美国约有300，000至600，000人患有活动性葡萄膜炎，但目前尚无临床上可接受的方法用于定量评估眼闪辉，从而快速、无创地诊断葡萄膜炎。目前诊断葡萄膜炎的方法包括用裂隙灯显微镜和检眼镜对眼睛进行彻底检查。尤其是较高水平的闪辉与患有某些形式的葡萄膜炎的患者的不良视力结果相关，例如与青少年关节炎相关的葡萄膜炎（Holland & Stiehm 2003）（Rosenberg等人2004）。这些测试既耗时又主观（Kempen等人，2008年）。目前唯一能够客观评估葡萄膜炎程度的FDA批准的设备是KOWA激光闪辉仪（FM-600）;这是一种台式设备，不适合广泛现场使用的成本效益。为了克服这一主要的健康需求，ChromoLogic LLC（CL）将开发和验证手持式眼闪测量仪（OFAM）-一种非侵入性仪器平台，在不到1分钟的时间内诊断疾病和辐射引起的血眼屏障破坏。使用早期原型获得的初步体外和试点临床数据证明了该技术的有效性。结果还显示，初始灵敏度远远超过（100倍）市售台式KOWA产品。在拟议项目的第一阶段，CL将进一步优化OFAM技术，并通过阶段性动物和临床研究证明其灵敏度和特异性。阶段的结果将用于FDA IDE申报。 公共卫生相关性：哺乳动物的眼睛和大脑一样，被认为是一个免疫特权器官，因为它包括多种抑制炎症的机制。这是为了保持视力而发展的生物学必需品。因此，任何眼睛炎症，称为葡萄膜炎，都会影响视力，有时甚至会永久性地损害视力。在任何给定的时间，美国大约有30万至60万人患有活动性葡萄膜炎。在西方世界，大约10%的视力障碍和在美国高达15%的全部失明病例归因于葡萄膜炎。的关键 管理活动性葡萄膜炎并防止由其导致的有害影响是及时可行的诊断。目前诊断葡萄膜炎的方法包括用裂隙灯显微镜和检眼镜检查对眼睛进行彻底检查-导致被称为眼闪的主观评分。特别是在患有某些形式的葡萄膜炎（例如与青少年关节炎相关的葡萄膜炎）的患者中，更高水平的耀斑与较差的视力结果相关。这些测试都是时间密集型的，而且很大程度上是主观的。KOWA激光闪光仪（FM-600）是目前唯一能够客观评估葡萄膜炎程度的设备;这是一种台式设备，既不具有成本效益，也不具有诊断灵敏度 早期葡萄膜炎因此，这项已有20多年历史的技术目前尚未用于临床诊断。考虑到葡萄膜炎可能导致的有害结果的严重性和规模以及缺乏客观的方法来诊断病症和监测所施用的任何治疗，迫切需要快速、便携和高度灵敏的诊断解决方案。