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Smart contact lens to measure head pressure in babies at risk of hydrocephalus

Tests a soft smart contact lens measuring pressure in infants at risk of hydrocephalus.

Key facts

Who runs it
Indiana University
Where
Indianapolis, United StatesSee the site
Trial code
Registry title
Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
Status
Enrolling by invitation
People taking part
25 people, planned
Started
24 Jan 2025
Expected to end
1 Jan 2029
Type of study
Interventional, 5 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Non-Invasive Pressure Monitor
Record updated
8 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies up to 12 months old who are being checked for hydrocephalus (fluid build-up in the brain), and healthy babies as a comparison group. It tests a soft contact-lens-like device that measures pressure in the head without surgery.

Age
0 Months to 12 Months
Sex
All
Disease stage
Babies being monitored for hydrocephalus, or healthy control babies.

Main reasons for not taking part

  • Known allergy to the materials in the contact lens or its adhesive
  • Open or closed wounds at or near the soft spot on top of the head (anterior fontanelle)
  • The soft spot on top of the head has already closed
  • Other conditions the medical team considers relevant

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Being monitored for hydrocephalus, or healthy controls

Who cannot take part

  • Known hypersensitivity to materials used in the contact lens and/or adhesive
  • Other conditions deemed relevant by the medical team
  • Open/closed wounds at/near the anterior fontanelle
  • Anterior fontanelle is closed

Where in United States

  • Riley Hospital for ChildrenIndianapolis, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 5 groups in the trial

  • Aim 1 ControlExisting treatment, for comparison

    Intervention at single time point not to interfere with standard of care procedures

    Treatment: Non-Invasive Pressure Monitor

  • Aim 1 HydrocephalusTreatment being tested

    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

    Treatment: Non-Invasive Pressure Monitor

  • Aim 2 Hydrocephalus, Shunt surgeryTreatment being tested

    Intervention pre- and post-operatively

    Treatment: Non-Invasive Pressure Monitor

  • Aim 3 Hydrocephalus, EVD ICP monitorTreatment being tested

    Intervention during standard of care monitoring of EVD ICP reading(s)/hydrocephalus evaluation (anterior fontanelle assessment and measurement of head circumference)

    Treatment: Non-Invasive Pressure Monitor

  • Aim 4 Hydrocephalus, Reservoir surgeryTreatment being tested

    Intervention pre- and post- ventricular reservoir tap(s)

    Treatment: Non-Invasive Pressure Monitor

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus
Plain-language title
Smart contact lens to measure head pressure in babies at risk of hydrocephalusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
8 October 2025