A High-Speed, User-Friendly, Handheld OCT System for Patients who are Unable to Cooperate

摘要 光学相干断层扫描（OCT）是诊断和监测视网膜病变的金标准， 视神经疾病临床OCT系统（带颏托的大型桌面器械）需要依从的受试者， 因此不适合用于婴儿、幼儿和不能配合眼睛的患者 成像（如身体残疾或在麻醉或重症监护下）。因为许多这些 患者无法就视力障碍或视力丧失进行沟通，难以实现疾病诊断 在不可逆转的视力丧失发生之前。这一人群的一个例子是重症监护中的早产儿， 早产儿视网膜病变（ROP）的风险。虽然手持式OCT（HH-OCT）已经导致了显著的 尽管人们对ROP的发展有深入的了解，但其用于疾病筛查的使用受到限制，部分原因是由于不良的 由于重量、人体工程学和成像速度，现有商业系统的可用性。需要 ROP的基于图像的分类是最近国际ROP分类委员会的主题。 显然需要一种商业化的、即时的、高速的、用户友好的手持式OCT系统， 提高婴儿、幼儿和无法配合成像的患者的护理标准。 Theia Imaging正在追求Theia 2高速、便携、用户友好、手持的商业化 OCT系统用于这些患者。我们的长期目标是使临床医生和研究人员能够收集 他们的患者急需的视网膜和/或视神经乳头的OCT成像。这将减少对 用于麻醉下的检查，并简化对视网膜和视神经的有价值信息的获取 头部在眼睛保健和一般保健的时候。 第二阶段的工作将建立在第一阶段开发的Theia 1系统的基础上，以实现FDA- 提交了一个手持式系统，该系统重量轻，具有小巧的人体工程学手柄和高分辨率成像 速度和强大的商业化途径。Theia Imaging将通过以下目标实现这一目标： 目标1：将T1原型改进为商业医疗器械。我们将改进探测器的设计 和OCT引擎，使我们能够扩大生产量，并降低设备的总体成本。目标二： 将T1软件改进为商业产品。我们将根据软件质量改进此软件 保证系统和提高可用性。目标3：初步研究、初步研究和510（k）申报。与 完善Theia 2系统后，我们将执行试点和关键人体研究，以支持510（k）申报。 该提案的预期成果是开发出一种商业上可行的300 kHz HH-OCT系统， 向FDA提交器械的510（k）申请。设备和相关软件都将 设计成可由眼科技术人员使用而无需专门培训。

ABSTRACT Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal and optic nerve diseases. Clinical OCT systems (large tabletop devices with chinrest) require a compliant subject, and thus are not suitable for use with infants, young children, and patients who are unable to cooperate for eye imaging (such as from physical disability or while under anesthesia or in intensive care). As many of these patients cannot communicate about vision disturbance or vision loss, diagnosis of disease is difficult to achieve before irrevocable vision loss occurs. One example of this population is preterm infants in intensive care and who are at risk for retinopathy of prematurity (ROP). While handheld OCT (HH-OCT) has led to significant insights into the development of ROP, its use for disease screening has been limited in part due to poor usability of the existing commercial systems due to weight, ergonomics and speed of imaging. The need for image-based classification of ROP was a subject of the recent International Classification of ROP Committee. There is a clear need for a commercial, point of care, high-speed, user-friendly handheld OCT system to improve the standard of care for infants, young children, and patients who are unable to cooperate for imaging. Theia Imaging is pursuing commercialization of the Theia 2 high-speed, portable, user-friendly, hand-held OCT system for use in these patients. Our long-term objective is to enable clinicians and researchers to gather much-needed OCT imaging of the retina and/or optic nerve head in their patients. This will decrease the need for examinations under anesthesia and simplify access to valuable information about the retina and optic nerve head at the time of eye care and general health care. This Phase II effort will build on the Theia 1 system developed in the Phase I, to result in an FDA- submission for a handheld system that is lightweight, with a small, ergonomic handpiece and imaging at high speed and a robust commercialization pathway. Theia Imaging will achieve this through the following Aims: Aim 1: Refine the T1 Prototype into a Commercial Medical Device. We will refine both the design of the probe and OCT engine allowing us to scale to production quantities and reduce the overall cost of the device. Aim 2: Refine the T1 Software into a Commercial Product. We will refine this software under a software quality assurance system and improve usability. Aim 3: Pilot Study, Pivotal Study and 510(k) Submission. With the refined Theia 2 system, we will execute pilot and pivotal human studies in support of a 510(k) submission The expected outcome of this proposal is the development of a commercially viable, 300 kHz HH-OCT system and a 510(k) submission for FDA clearance of the device. Both the device and associated software will be designed to be usable by ophthalmic technicians without the need for specialized training.