Retinopathy of Prematurity Clinical Trial
Official title:
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.
Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at
high risk for ROP during their stay in the neonatal intensive care unit (NICU).
- The number of sites - 5 centers in the US
- The number and description of participants: 500 babies with birth weights of <1251g
Study Interventions and Measures:
Data from RetCam digital images obtained as part of clinical care during the routine
diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central
reading center. These de-identified images will be graded by Certified Image Readers.
Results of image gradings will be sent back via secure web-based platform to the Clinical
Center. The primary outcome measure is the turnaround time from uploading the images to
feedback to the Clinical Center. The secondary outcome measure is the time required to
obtain retinal images for babies scheduled for ROP examination in the NICU (relative
cost-effectiveness).
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