Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

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).

Inclusion Criteria:

1. Babies with birth weights of <1251g

2. Babies having clinical examinations to screen for ROP

Exclusion Criteria:

- 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.

- Ocular Abnormalities: Babies will be excluded from this study if they have major
congenital abnormalities in one or both eyes including microphthalmos, anophthalmos,
anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma,
chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid
abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely
affect vision, would also exclude a baby from participation. Minor abnormalities that
would not be expected to affect vision may not be exclusion criteria including
Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.