Proparacaine and Mydriatic Eye Drops

A. Randomization of subjects: Infants will be randomized to receive Proparacaine versus no
intervention based on computerized randomization performed by our statistician. Due to the
lack of a placebo group, practitioners present at the time of examination will not able to
be blinded to group assignment. Each infant will only be enrolled for one examination.

B. Monitor setup/application: The Central Nervous System (CNS) Neonatal Neurological Monitor
(Moberg Research) will be used to videotape each patient encounter and record vital sign
information during the study period. The CNS monitor will record physiologic variables
indirectly via cables attached to the bedside monitor. Before scheduled eye drop
administration takes place, the appropriate connections between the bedside monitor and CNS
monitor will be made in order to continuously record heart rate, respiratory rate, pulse
oximetry, and blood pressure. A video camera attached to the CNS monitor will also be
positioned to capture the subjects' facial activity and gross body movements. The monitor
will be set up with enough time prior to eye drop administration such that baseline data can
be collected before any intervention is performed. In addition, a video recording of the
method of eyedrop administration will be assessed. The monitor will remain in place up to 5
minutes after completion of eye drop administration.

C. Eye drop administration: The CNS Monitor will be in place at least 3 minutes prior to
administration of any eye drops to record baseline data on the infant. One drop of
Proparacaine anesthetic ophthalmic solution will be applied to each eye of infants
randomized to receive Proparacaine prior to the mydriatic eye drops. At least 30 seconds and
no longer than 5 minutes after administration of Proparacaine, the mydriatic eye drops will
be given as per routine standard practice for ophthalmologic examinations in the NICU.