Optic Nerve Head Analyzer for Glaucoma

描述（由申请人提供）：视盘摄影仍然是记录青光眼患者视神经乳头（ONH）状态的主要方法。ONH条件下的纵向变化通过仔细研究结构来监测，例如杯盘比和血管取向变化。虽然眼科医生很擅长这项工作，但他们只能做出定性判断。也就是说，由于时间限制和缺乏高质量的计算机化工具，他们通常无法进行精确的测量，以发现疾病早期发生的微小变化。 提出了一种ONH图像分析仪，该分析仪将应用“主动形状模型”（ASM）作为分割特征的手段，并为患者的纵向图像在OHN中产生“形状”的统计表示。 ASM是一种相对较新的技术，用于对可能具有相似性但细节可能不同的结构进行建模。在本申请中使用的ASM将捕获同一个人的ONH的纵向变异性。ASM将生成血管空间位置和形状变化的统计表示。它还将应用于其他结构，如视盘和视杯，以检测和量化其形状和大小的细微变化。 使用ASM分析ONH结构的变化尚未在文献中描述。由于这种经典的摄影技术的普遍性，成功应用ASM分析ONH变化将对其临床应用产生重大影响。具体目标是：1）证明可以精确地检测和测量OHN上血管位置的细微变化，以及2）将由于青光眼的进展引起的ONH中血管的变化相关联。 商业化潜力：ONH分析仪系统可以提供视盘和视网膜血管的结构和配置变化的定量信息，因此有可能提高青光眼的诊断技术和诊断时间。该系统最大限度地减少了用户的参与，并使用现有的数字摄影技术，目前使用的办公室和诊所的眼科医生。因此，从成本和上市时间评估以及与现有设备的集成角度来看，该器械的商业影响非常显著。

DESCRIPTION (provided by applicant): Optic disc photography remains the mainstay for recording the state of the optic nerve head (ONH) for glaucoma patients. Longitudinal changes in the ONH condition are monitored by meticulous study of the structures, such as the cup to disc ratio and vessel orientation variations. Although the ophthalmologists are quite adept at this task, they can only make qualitative judgments. That is, because of time constraints and the lack of quality computerized tools, they normally cannot make precise measurements in order to detect small changes that occur early in the disease. An ONH Image Analyzer is proposed that will apply an "Active Shape Model" (ASM) as a means for segmenting features and produce a statistical representation of the "shapes" in the OHN for the patient's longitudinal images. The ASM is a relatively new technique used for modeling structures that may have similarities, but can vary in the details. The ASM, as used in this application, will capture the longitudinal variability in the same person's ONH. The ASM will produce statistical representation of the changes in spatial location and shape of vessels. It will also be applied to other structures, such as the optic disc and cup, to detect and quantify subtle changes in their shape and size. The use of ASM for analyzing the changes in the ONH structure has not been described in the literature. Because of the pervasiveness of this classical photographic technology, the successful application of ASM for analyzing ONH changes will make a significant impact on its clinical use for many more decades. Specific aims are: 1) to demonstrate that subtle changes in vessels location on the OHN can be detected and measured precisely, and 2) to correlate changes in the vessels in the ONH due to the progression of glaucoma. Commercialization Potential: The ONH Analyzer System can provide quantitative information for the changes in structure and configuration of the optic disc and retinal vessels and thus has the potential to advance the diagnostic techniques and time to diagnosis for glaucoma. The system minimizes user involvement and uses existing digital photographic technology currently used in the offices and clinics of ophthalmologists. As such, the commercial impact of this device is significant from a cost and time to market assessment as well as integration to existing equipment perspective.