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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1 Control | Active Comparator | Intervention at single time point not to interfere with standard of care procedures |
|
| Aim 1 Hydrocephalus | Experimental | Intervention at single time point during standard of care hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference), unless further assigned to supplemental arm following standard of care surgical procedure |
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| Aim 2 Hydrocephalus, Shunt surgery | Experimental | Intervention pre- and post-operatively |
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| Aim 3 Hydrocephalus, EVD ICP monitor | Experimental | Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference) |
|
| Aim 4 Hydrocephalus, Reservoir surgery | Experimental | Intervention pre- and post- ventricular reservoir tap(s) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Pressure Monitor | Device | Modified smart soft contact lens and cap with reader coil |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of modified smart soft contact lens evaluation of external intracranial pressure at single time point (Aim 1) | ICP readings from the device will be compared to standard of care assessments and measurements in healthy control patients and hydrocephalus patients | 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) | ICP readings from the device will be compared to standard of care assessments and measurements in patients undergoing shunt insertion | 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) | ICP readings from the device will be compared to standard of care assessments and measurements in patients with an EVD/ICP monitor | 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) | ICP readings from the device will be compared to standard of care assessments and measurements in patients with a reservoir, pre- and post-tap | Continuously measured for up to 4 hours prior to reservoir tapping and continuously measured for up to 4 hours after reservoir tapping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jignesh Tailor | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm
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