Non-Contact Ophthalmic Optical Pachymeter

描述（由申请人提供）：人体角膜厚度的准确体内测量（角膜厚度测量）是眼科学中的重要诊断程序。角膜厚度测量是屈光手术（如LASIK）的重要先导，其中角膜厚度决定了适当的角膜瓣厚度设置并设置了激光消融的上限。最近发表的NEI赞助的高眼压治疗研究（OHTS）发现，角膜厚度与眼内压一样重要，是青光眼发生的危险因素。作为OHTS的结果，角膜厚度测量已成为高眼压和其他青光眼可疑患者临床检查的标准部分。基于低相干干涉测量（类似于光学相干断层扫描或OCT）的新一代光学厚度计有望为厚度测量带来更高分辨率和非接触测量的好处。这一第一阶段的小型企业创新研究申请建议开发新技术，通过使用一种新颖的、易于使用的共光路光谱干涉测量系统设计，（手持式或裂隙灯安装探头，减少轴向定位的限制）和高分辨率（预计<3 p.m的可重复性）在一个坚固和廉价的包装（没有移动部件，预计成本<$10K/单位）。我们的研究团队包括光电器件表征和制造方面的专家，以及我们的顾问，其中包括OCT技术开发和视网膜和眼前节成像应用方面的学术和临床先驱。 该提案的具体目标是： 1.构建一种新型的共路光谱干涉光学厚度计引擎，具有高分辨率（<3微米的重复性）和高扫描速率（20 Hz），具有耐用和廉价的组件; 2.设计并制造两个手持式角膜厚度计探头原型，适用于青光眼评估、术前评估和术中评估; 3.开发用户友好的软件，实现自动A扫描捕获和角膜厚度计算; 4.在校准的参考反射镜和两只眼库眼睛中演示角膜厚度计的体内操作，并向我们的临床顾问提供原型设备，以便在NIH的单独支持下进行体内测试。

DESCRIPTION (provided by applicant): Accurate in-vivo measurement of human corneal thickness (pachymetry) is an important diagnostic procedure in ophthalmology. Pachymetry is an important precursor to refractive surgery procedures such as LASIK, where the corneal thickness determines the appropriate flap thickness setting and sets the upper limit for laser ablation. The recently published NEI-sponsored Ocular Hypertension Treatment Study (OHTS) found that corneal thickness is just as important as intraocular pressure as a risk factor for the development of glaucoma. As a results of OHTS, pachymetry has become a standard part of the clinical examination for ocular hypertensives and other glaucoma suspects. A new generation of optical pachymeters based on low-coherence interferometry (similar to optical coherence tomography or OCT) is poised to bring the benefits of higher resolution as well as noncontact measurement to pachymetry. This Phase I Small Business Innovative Research application proposes to develop new technology, which will significantly advance optical pachymetry by use of a novel, common-path spectral interferometric system design which delivers ease of use (hand-held or slitlamp-mounted probe, reduced constraints on axial positioning) and high resolution (projected <3 p.m repeatability) in a robust and inexpensive package (no moving parts, projected cost <$10K/unit). Our team of investigators includes experts in optoelectronic device characterization and manufacturing, as well as our consultants who include academic and clinical pioneers in OCT technology development and applications in retinal and anterior segment imaging. The specific aims of the proposal are to: 1. Construct a novel common-path spectral interferometric optical pachymeter engine featuring high resolution (<3 microns repeatibility) and high scan rate (20 Hz), with robust and inexpensive components; 2. Design and construct two handheld pachymeter probe prototypes suitable for evaluation for glaucoma, presurgical, and intra-surgical applications; 3. Develop user-friendly software enabling automatic A-scan capture and corneal thickness calculation; 4. Demonstrate pachymeter operation in calibrated reference reflectors and two eye bank eyes in vivo, and provide a prototype device to our clinical consultant for in vivo testing under separate NIH support.