Aspheric SDOCT Imaging System for Dry Eye and Cornea Diagnostics

描述（由申请人提供）：干眼病是一种折磨，影响多达20%的50岁以上的美国人口，甚至在亚太地区更为普遍。干眼症治疗目前是一个价值17亿美元的市场，以每年10%的速度增长。治疗主要是姑息性的，包括热敷和滴眼液。TearScience最近发布了LipiFlow来热改善睑板腺功能。角膜营养不良包括上皮、间质和内皮的病变和损伤。每年有250万美国人遭受眼部损伤。每年有80,000例角膜移植和移植手术。圆锥角膜在2000年感染1例。每年有3500万美国人戴隐形眼镜，大约有300万美国人接受某种屈光手术。隐形眼镜行业是一个价值30亿美元的零售行业，用于疾病管理和屈光矫正的外科手术和设备的投资持续强劲。然而，随着这些外前部疾病状态的流行，光谱域光学相干断层扫描的能力尚未确定一个角色。本提案的目的是开发一种更适合于临床上有用的角膜、泪膜和内眼睑、结膜和巩膜组织超微结构成像的成像设备。值得注意的设计目标是提供光学适合成像曲面与宽视场。要实现这一目标，有三个可分离的技术挑战：1。将扫描的焦场反转以匹配角膜表面；2. 平衡光路长度，使一个球面成像为一个平面在恒定的成像深度；3. 引入光学元件，允许这样的设计是紧凑和成本效益。第一阶段活动的预期结果是一个前段扫描仪的工作原型，它独特地适合于成像外前段结构，将通过台架测试和小动物成像进行验证。这项工作将为外前段探针的产品开发和商业化铺平道路。该产品将提供一种新的诊断工具，以支持腺体和肌肉功能障碍以及干眼病的评估和治疗。此外，该产品将改善角膜表面的成像，具有很大的潜力，有助于诊断和治疗角膜营养不良、圆锥角膜和伤口愈合，具有真正的角膜缘到角膜缘的能力。此外，该产品将为虹膜-角膜角的评估提供新的视角

DESCRIPTION (provided by applicant): Dry Eye disease is an affliction that impacts as many much as 20% of the U.S. population over age 50, and is even more prevalent in the Asia Pacific. Dry eye therapies are currently a $1.7B market, growing at 10% annually. Treatment is primary palliative, involving warm compresses and eye drops. TearScience recently released LipiFlow to thermally improve meibomian gland function. Corneal dystrophies include disease and injury of the epithelium, stroma and endothelium. 2.5M Americans suffer from eye injury each year. There are 80,000 corneal transplants and grafts annually. Keratoconus affects 1 in 2000. 35M Americans wear contact lenses and approximately 3M Americans undergo some sort of refractive surgery each year. The contact lens industry is $3B retail industry, and investment in surgical procedures and devices for management of disease and for refractive correction continues to be strong. Yet with the prevalence of these outer anterior disease states, the capabilities of spectral domain optical coherence tomography have yet to define a role. The objective of this proposal is to develop an imaging handpiece that is more suited to clinically useful imaging of the cornea, the tear film, and the tissue ultrastructure of the inner eyelid, conjunctiva and sclera. The notable design objective is to provide optics suited to imaging curved surfaces with a wide field of view. In accomplishing this objective, there are three separable technical challenges: 1. Invert the scanned focal field to match the surface of the cornea; 2. Equalize the optical path lengths so that a spherical surface is imaged to a plane at constant image depth; 3. Introduce optical elements that allow such a design to be compact and cost effective. The anticipated outcome of the Phase I activities is a working prototype of an anterior segment scanner uniquely suited to imaging the outer anterior segment structures which will have been verified through bench testing and validated through small animal imaging. This work will pave the way to product development and commercialization of the outer anterior segment probe. That product will provide a new diagnostic tool to support the evaluation and treatment of glandular and muscular dysfunctions and dry eye disease. Additionally, the product will improve imaging of the cornea surface with significant potential to aid in the diagnosis and treatment of corneal dystrophies, keratoconus and wound healing with true limbus-to-limbus capabilities. Further, this product will offer a new view to the irido-corneal angle for assessment of narrow angle glaucoma. PUBLIC HEALTH RELEVANCE: Dry Eye disease is an affliction that impacts as many much as 20% of the U.S. population over age 50, 2.5M Americans suffer from eye injury each year, 35M Americans wear contact lenses, and approximately 3M Americans undergo some sort of refractive surgery each year. Spectral Domain Optical Coherence Tomography (SDOCT) is a technology that is used for imaging the eye to aid in diagnosis of some diseases of the eye, but it has yet to be tailored specifically to imaging the tear film, cornea, and other structures in th front of the eye that are associated with dry eye and refractive errors. Bioptigen is proposing the development of a new scanner for SDOCT systems that will enable high quality imaging of these structures and could greatly aid in research on these structures of the eye and in the diagnosis of diseases and treatment of injuries of the front of the eye.