Fully Automatic ROP Screening System: NeoScan

 描述（由申请人提供）：该II期项目的动机是与早产儿视网膜病变（ROP）筛查相关的当前问题。ROP是婴儿失明的主要原因。近年来，有ROP风险的婴儿数量一直在增加。在美国，早产率从1981年的9.4%上升到2010年的12%，早产儿总数超过50万。早产儿疾病的管理在很大程度上取决于及时的筛查和干预。不幸的是，ROP筛查的低报销水平，偏远地区ROP筛查设备不足，以及长期暴露于医疗事故行为，使得难以为有风险的新生儿提供适当的护理。为了缓解这些问题，VisionQuest Biomedical LLC及其合作者奥克兰大学（MI）和南德克萨斯州视网膜研究所（RIST）将展示和测试NeoScan，这是一系列旨在改善ROP管理和检测的软件产品。NeoScan由两个产品组成：NeoScan-Assist和NeoScan-Detect。NeoScan-Assist旨在通过准确量化血管迂曲度和口径（已证明与ROP晚期相关的因素），提高生产率并减少新生儿医疗保健提供者解读的可变性。NeoScan-Assist的目的是减少ROP晚期诊断的变异性，并为新生儿ROP的准确筛查和分期提供工具。NeoScan-Detect旨在自动识别需要眼科医生进一步检查的婴儿。该项目的目标将通过三个具体目标实现。在目标1中，我们将通过将该项目第一阶段开发的方法产品化，完成NeoScan-Assist的产品开发。在目标2中，将进行一项前瞻性临床研究，以评价NeoScan-Assist的有效性，并为NeoScan-Detect的确认提供数据。在目标3中，我们将演示NeoScan-Detect的图像处理技术。在该II期项目结束时，我们将准备提交NeoScan-Assist的FDA 510（k）上市许可，并且在提交该申请的同时，我们将进行临床试验以证明NeoScan-Detect的安全性和有效性，为该产品的FDA上市许可申请做准备。

 DESCRIPTION (provided by applicant): This Phase II project is motivated by current issues associated with screening for retinopathy of prematurity (ROP). ROP is the leading cause of blindness in infants. In recent years the number of infants at risk for ROP has been increasing. In the United States, the rate of prematurity has risen from 9.4% of all births in 1981 to 12% in 2010, for a total of over 500,000 preterm births. Preterm neonate disease management depends largely on timely screening and intervention. Unfortunately, low reimbursement levels for ROP screening, insufficient equipment for ROP screening in remote locations, and long-term exposure to medical malpractice actions make it difficult to provide appropriate care to neonates at risk. To mitigate these problems, VisionQuest Biomedical LLC and its collaborators, Oakland University (MI) and the Retina Institute of South Texas (RIST), will demonstrate and test NeoScan, a family of software products aimed at improving the management and detection of ROP. NeoScan consists of two products: NeoScan-Assist and NeoScan-Detect. NeoScan-Assist is aimed at increasing the productivity and reducing the variability in interpretation by th neonatal healthcare providers through accurate quantification of vasculature tortuosity and caliber, factors that have been demonstrated to correlate with the presence of advanced stages of ROP. The objectives of NeoScan-Assist are to reduce variability in the diagnosis of advanced stages of ROP and to provide a tool for accurate screening and staging of ROP in neonates. NeoScan-Detect is aimed at automatically identifying infants that need further examination by an ophthalmologist. The objectives of this project will be accomplished through three specific aims. In Aim 1 we will finalize the product development of NeoScan-Assist by productizing the methods developed during Phase I of this project. In Aim 2, a prospective clinical study will be performed to evaluate the effectiveness of NeoScan-Assist and to provide data for validation of NeoScan- Detect. In Aim 3 we will demonstrate the image processing techniques that will be part of NeoScan-Detect. At the end of this Phase II project we will be ready to submit an FDA 510(k) market clearance for NeoScan-Assist, and, in parallel with that submission, we will perform a clinical trial to demonstrate the safety and effectiveness of NeoScan-Detect in preparation for an FDA market clearance submission of that product.