Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (e-ROP) Study
e-ROP is a multi-center study designed to evaluate the validity, reliability, feasibility and cost-effectiveness of a telemedicine system to detect eyes of at-risk babies in need of a diagnostic examination by an ophthalmologist experienced in retinopathy of prematurity (ROP). The study is funded by the National Eye Institute of NIH.
Why is it important?
ROP is the leading cause of treatable childhood blindness and is becoming an increasing problem in the underserved areas of the US and Canada, reaching epidemic rates in rapidly developing countries. At present, premature babies requiring treatment are identified by skilled ophthalmologists who visit neonatal units to examine babies at risk, but because fewer than 10% of babies examined require treatment, this is an inefficient use of skilled and costly personnel. There are two main difficulties in providing the required diagnostic examinations for babies at risk for ROP. First, there are too few experts in ROP worldwide to meet the growing demand for ROP evaluations. Second, there is an inherent variability in the results from diagnostic examinations performed by ophthalmologists. A potential solution to address both the paucity of experts who can evaluate ROP and variability in the quality of evaluations is to develop a telemedicine system that uses digital retinal imaging to detect sight-threatening disease in an efficient and cost-effective manner.
A telemedicine approach rigorously tested for reliability and validity from this study could greatly reduce the number of examinations that are needed to be performed by specially trained ophthalmologists, and significantly increase the number of babies who receive appropriate timely evaluations.
The study will enroll 2000 babies with birth weight of 1250 grams or less from 12 neonatal intensive care units in the United States and Canada. All babies will undergo both digital retinal imaging and indirect ophthalmoscopic examinations on the same day. Wide-field digital retinal images of both eyes (5 retinal images per eye) will be captured by non-physician Certified ROP Imagers using standardized imaging protocols. The RetCam Shuttle® (Clarity Medical Systems, Pleasanton, CA), will be used to capture wide field retinal images. Study data including demographic, diagnostic examinations, images and safety information will be securely uploaded from each clinical center to the study server. Retinal images will be graded by Trained Readers using a standardized protocol to identify eyes with Referral-Warranted ROP (RW-ROP). Results of the gradings will be compared to the diagnostic examinations being performed on each child at the same session when the images are taken. For quality assurance, some images will also be graded by ROP experts (Expert Readers).