Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Children's Hospital of Philadelphia
With
National Eye Institute (NEI)
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).
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Babies with birth weights of \<1251g
2. Babies having clinical examinations to screen for ROP
You may not be if
Referral from an outside hospital for treatment of serious ROP that is performed before imaging can be obtained.
Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study.
Clareo Health | Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project