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.

Public Health 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.

National Institute of Health (NIH)
National Eye Institute (NEI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZEY1-VSN (01))
Program Officer
Schron, Eleanor
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Children's Hospital of Philadelphia
United States
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Daniel, Ebenezer; Ying, Gui-Shuang; Siatkowski, R Michael et al. (2017) Intraocular Hemorrhages and Retinopathy of Prematurity in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity (e-ROP) Study. Ophthalmology 124:374-381
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Quinn, Graham E; Barr, Charles; Bremer, Don et al. (2016) Changes in Course of Retinopathy of Prematurity from 1986 to 2013: Comparison of Three Studies in the United States. Ophthalmology 123:1595-600
Karp, Karen A; Baumritter, Agnieshka; Pearson, Denise J et al. (2016) Training retinal imagers for retinopathy of prematurity (ROP) screening. J AAPOS 20:214-9
Morrison, David; Bothun, Erick D; Ying, Gui-Shuang et al. (2016) Impact of number and quality of retinal images in a telemedicine screening program for ROP: results from the e-ROP study. J AAPOS 20:481-485
Quinn, Graham E; Ying, Gui-Shuang; Repka, Michael X et al. (2016) Timely implementation of a retinopathy of prematurity telemedicine system. J AAPOS 20:425-430.e1
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