Telemedicine Approaches to Evaluating Acute-phase ROP - eROP

描述(由申请人提供)：我们建议进行一项多中心临床研究，评估ROP远程医疗评估系统的有效性、可靠性、可行性、安全性和相对成本效益，以检测符合RW-ROP标准的高危婴儿的眼睛，并需要具有ROP经验的眼科医生进行诊断评估。我们将：1.使用灵敏度和特异度计算系统的准确性，以提供远程评估，对照由经过严格ROP诊断检查培训的研究认证眼科医生进行的“金标准”间接眼科检查的结果(有效性)；2.确定阅读器内部和阅读器间的一致性，以确定数字图像是否表明眼睛需要由具有ROP经验的眼科医生进行诊断性间接眼底检查(可靠性)；3.确定是否可以对每个婴儿进行成像评估(可行性)；4.检查与数字成像相关的眼部和全身并发症，并与眼科医生进行的诊断性检查相比较(安全性)；5.比较采用远程医疗视网膜成像系统的成本和收益与目前间接眼底检查的成本和效益(成本效益)。在美国和加拿大的大型临床中心，出生体重为1251克的婴儿将在同一天接受数字视网膜成像和临床指示的间接眼底检查。非医生成像器将使用标准化的成像协议捕获双眼的广域数字图像。Retcam Shuttle(R)(Clarity Medical Systems，Pleasanton，CA)是一种角膜接触式相机，可以捕捉宽视野(130度视野)的视网膜图像。所有研究数据，包括人口统计、诊断检查、成像和安全信息，都将安全地传输到研究服务器。视网膜图像将由训练有素的读者使用标准化的方案进行分级，以识别具有RW-ROP的眼睛。评分结果将与同一次会议上的诊断检查进行比较。 相关性(由申请人提供)：早产儿视网膜病变(ROP)是可治疗的儿童失明的主要原因。在美国和加拿大服务不足的地区，ROP正成为一个日益严重的问题，在快速发展的国家也发现了流行率。我们认为，使用数字视网膜成像和标准化分级相结合的系统方法提供了改善ROP护理的质量、途径和效率的机会。

DESCRIPTION (provided by applicant): We propose a multi-center clinical study will evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of an ROP telemedicine evaluation system to detect eyes of at-risk babies who meet RW- ROP criteria and need of a diagnostic evaluation by an ophthalmologist experienced in ROP. We shall: 1. Calculate the accuracy, using sensitivity and specificity, of the system to provide remote evaluations when compared with the findings of a "gold standard" indirect ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously trained in ROP diagnostic examinations (validity); 2. Determine intra-reader and inter-reader agreement for deciding whether digital images indicate that the eye are in need of diagnostic indirect ophthalmoscopy by ophthalmologist experienced In ROP (reliability); 3. Determine whether imaging evaluation can be achieved for each baby (feasibility); 4. Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety); 5. Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness). Babies with birth weights of <1251g at large clinical centers in the US and Canada will undergo both digital retinal imaging and clinically indicated indirect ophthalmoscopic examinations on the same day. Wide-field digital images of both eyes will be captured by non-physician imagers using standardized imaging protocols. The RetCam Shuttle(R) (Clarity Medical Systems, Pleasanton, CA) a corneal-contact camera that captures wide field (130 degree field of view) retinal images, will be used. All study data, including demographic, diagnostic examinations, imaging, and safety information, will be securely transmitted to a Study server. Retinal images will be graded by Trained Readers using a standardized protocol to identify eyes with RW- ROP. Results of the gradings will be compared to the diagnostic examinations at the same session. RELEVANCE (provided by the applicant): Retinopathy of prematurity (ROP) is the leading cause of treatable childhood blindness. ROP is becoming an increasing problem in underserved areas of the US and Canada, and epidemic rates are being found in rapidly developing countries. We submit that a systematic approach to use digital retinal imaging combined with standardized grading offers the opportunity to improve quality, access and efficiency of ROP care.