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Healthy Little Eyes

NCT05971446 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-05-14

No results posted yet for this study

Summary

The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE).

Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Encephalopathy
  • Encephalopathy

Interventions

DEVICE

Visual Evoked Potential (VEP)

Small gold-cup electrodes will be placed on the participant's head using a small dot of adhesive paste. The handheld device is then connected to the electrodes, and the participant's eyes are exposed to a light flicker. Each eye will be tested separately, and while testing one eye, the other eye may be patched.

DEVICE

Electroretinogram (ERG)

Skin electrodes will be placed under each eye. Eyes will then be exposed to a flashing light. Each eye will be tested separately and while testing one eye, the other eye may be patched.

Sponsors & Collaborators

  • Meriter Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Pelin Cengiz, MD · University of Wisconsin, Madison

Eligibility

Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2027-07-31
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971446 on ClinicalTrials.gov