A portable ultra-widefield fundus camera for nonmydriatic examination of retinopathy of prematurity

标题：用于早产儿视网膜病变非散瞳检查的便携式超宽视野眼底照相机 摘要：及时筛查是预防视网膜病变导致的视力损害和失明的重要步骤 早产儿（ROP）众所周知，广角眼底检查对于ROP的筛查、诊断和治疗是必不可少的 和治疗评价。然而，现有的儿科眼底照相机具有三个主要限制： 视野（FOV）、高成本和散瞳成像。该SBIR旨在开发一种儿科摄像机（PedCam）， 超宽视野（220 o）、低成本（25 K美元）和非散瞳设备，以克服现有眼底的所有三个限制 相机在第一阶段，我们已经构建了一个实验室原型，用于概念验证，并展示了 超宽视野眼底照相中使用跨面照明的可行性。通过释放整个 光瞳仅用于成像目的，跨部分平面照明显著简化了光学设计 关于PedCam在第二阶段，我们建议优化光学设计，标准化制造， 关键组件的流程，开发易于使用的成像平台，并验证PedCam的ROP 筛选第一个目标是220° PedCam的原型开发。申报器械的关键质量标准 单次拍摄图像的FOV为220°;中央视网膜分辨率为20 µm;周边视网膜分辨率为40 µm。在 与近红外线的指导协调，以尽量减少视网膜的可见光照射，三通道 照明器将允许平坦部的容易识别 质量.第二个目的是对220° PedCam进行ROP筛查的临床验证。为了定量比较， 将在UIC Retina Clinic使用原型PedCam和临床RetCam 3采集眼底图像。 标准ROP检查将使用双目间接检眼镜（BIO）。成功标准 II期研究旨在验证非散瞳PedCam的性能上级 散瞳Retcam;并证明使用220° PedCam进行全面儿科检查的潜力 眼底检查直到锯齿缘，这是目前使用130° Retcam无法实现的。年底前 第二阶段，220 o PedCam的技术规范将最终确定，以备510（k）准备， FDA批准。

Title: A portable ultra-widefield fundus camera for nonmydriatic examination of retinopathy of prematurity Summary: Prompt screening is an essential step to prevent visual impairment and blindness due to retinopathy of prematurity (ROP). It is known that widefield fundus examination is essential for ROP screening, diagnosis and treatment evaluation. However, existing pediatric fundus cameras have three major limits: limited field of view (FOV), high cost, and mydriatic imaging. This SBIR is to develop a pediatric camera (PedCam) which is an ultra-widefield (220o), low-cost ($25K), and non-mydriatic device to overcome all three limits of existing fundus cameras. In Phase I, we have constructed a lab prototype for proof-of-concept validation, and demonstrated the feasibility of using trans-pars-planar illumination for ultra-widefield fundus photography. By freeing the whole available pupil for imaging purpose only, the trans-pars-planar illumination significantly simplifies optical design of the PedCam. During the Phase II, we propose to optimize the optical design, standardize the fabrication process of key components, develop an easy-to-use imaging platform, and validate the PedCam for ROP screening. The first aim is prototype development of a 220° PedCam. Key specifications of the proposed device are: 220° FOV in a single-shot image; 20 µm resolution for central retina; and 40 µm for peripheral retina. In coordination with a near infrared guidance to minimize the visible light exposure to the retina, a three-channel illuminator will allow easy identification of the pars plana to enable high illumination efficiency with optimal image quality. The second aim is clinical validation of the 220° PedCam for ROP screening. For quantitative comparison, fundus images will be acquired using both the prototype PedCam and a clinical RetCam3 at UIC Retina Clinic. Binocular indirect ophthalmoscopy (BIO) will be used for standard ROP examination. Success criterion of the Phase II study is to verify that the non-mydriatic PedCam can provide performance superior to that of the mydriatic Retcam; and to demonstrate the potential of using the 220° PedCam for comprehensive pediatric fundus examination up to the ora serrata, which is not currently possible with the 130° Retcam. By the end of the phase II, technical specification of the 220o PedCam will be finalized for the 510(k) preparation required for FDA clearance.