The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are: * Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without * Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.
Age range
0 Months – 12 Months
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1)
Timeframe: Day 1, continuously measured for up to 4 hours
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after shunt surgery (Aim 2)
Timeframe: Continuously measured for up to 4 hours prior to shunt surgery and continuously measured for up to 4 hours after shunt surgery
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure during hydrocephalus evaluation (Aim 3)
Timeframe: Continuously measured for up to 4 hours while EVD/ICP monitoring is in place
Efficacy of modified smart soft contact lens evaluation of external intracranial pressure before and after reservoir taps (Aim 4)
Timeframe: Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping