Aspheric SDOCT Imaging System for Dry Eye and Cornea Diagnostics

用于干眼和角膜诊断的非球面 SDOCT 成像系统

• 批准号: 8394731
• 负责人: Eric L. Buckland
• 金额: $ 28.85万
• 依托单位: BIOPTIGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8394731
• 关键词: Affect; Age; Am 80; American; Angle-Closure Glaucoma; Animals; Anterior; Arts; Asia; Canis familiaris; Contact Lenses; Cornea; Corneal dystrophy; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Management; Elements; Endothelium; Epithelium; Evaluation; Eye; Eye Injuries; Eye diseases; Eyedrops; Eyelid structure; Film; Functional disorder; Government; Housing; Image; Industry; Injury; Investments; Keratoconus; Keratoplasty; Length; Marble; Marketing; Mechanics; Meniscus structure of joint; Molds; Muscle; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Oryctolagus cuniculus; Outcome; Pathology; Performance; Persons; Phase; Population; Prevalence; Refractive Errors; Research; Role; Scanning; Sclera; Small Business Innovation Research Grant; Sorting - Cell Movement; Specific qualifier value; Structure; Surface; System; Technology; Testing; Time; Tissues; Work; Wound Healing; base; commercialization; conjunctiva; cost effective; design; disease diagnosis; eye dryness; improved; meibomian gland; novel diagnostics; optical imaging; palliative; performance tests; product development; prototype; tool

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.

描述（由申请人提供）：干眼症是一种困扰，影响多达20%的美国50岁以上人口，在亚太地区更为普遍。干眼症治疗目前是一个17亿美元的市场，每年增长10%。治疗主要是姑息性的，包括热敷和滴眼液。TearScience最近发布了LipiFlow，以热改善睑板腺功能。角膜营养不良包括上皮、基质和内皮的疾病和损伤。每年有250万美国人遭受眼部损伤。每年有8万例角膜移植和移植手术。圆锥角膜的发病率为1/2000。每年有3500万美国人戴隐形眼镜，大约300万美国人接受某种屈光手术。隐形透镜行业是30亿美元的零售行业，并且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，随着这些外前病变状态的流行，谱域光学相干断层扫描的能力还没有定义一个角色。本提案的目的是开发一种成像机头，其更适合于角膜、泪膜以及内眼睑、结膜和巩膜的组织超微结构的临床有用成像。值得注意的设计目标是提供适合于成像具有宽视场的弯曲表面的光学器件。在实现这一目标的过程中，存在三个可分离的技术挑战：1。反转扫描的焦场以匹配角膜的表面; 2.调整光程长度，使得球面以恒定的像深成像到平面上; 3.引入允许这种设计紧凑且具有成本效益的光学元件。第I阶段活动的预期成果是眼前节扫描仪的工作原型，该扫描仪专门适用于对外部眼前节结构进行成像，将通过实验室测试进行验证，并通过小动物成像进行确认。这项工作将铺平道路的产品开发和商业化的外眼前节探针。该产品将提供一种新的诊断工具，以支持腺和肌肉功能障碍和干眼病的评估和治疗。此外，该产品将改善角膜表面的成像，具有帮助诊断和治疗角膜营养不良、圆锥角膜和伤口愈合的巨大潜力，具有真正的角膜缘到利姆布斯能力。此外，该产品将提供一个新的观点，虹膜角膜角的评估 窄角型青光眼 公共卫生相关性：干眼症是一种困扰，影响多达20%的50岁以上的美国人口，每年有250万美国人遭受眼睛损伤，3500万美国人佩戴隐形眼镜，每年约有300万美国人接受某种屈光手术。谱域光学相干断层扫描（SDOCT）是一种用于对眼睛进行成像以帮助诊断眼睛的一些疾病的技术，但是它还没有被专门定制为对泪膜、角膜和与干眼症和屈光不正相关联的眼睛前部的其他结构进行成像。Bioptigen提出 开发用于SDOCT系统的新扫描仪，该扫描仪将能够对这些结构进行高质量成像，并且可以极大地帮助对眼睛的这些结构的研究以及对疾病的诊断和对眼睛前部的损伤的治疗。