Healthy Little Eyes

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05971446
Status
Recruiting
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Conditions

  • Encephalopathy
  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Encephalopathy

Eligibility Criteria

Sex
ALL
Age
N/A - 36 Months
Healthy Volunteers
Accepted

Interventions

  • Visual Evoked Potential (VEP) — DEVICE
    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.
  • Electroretinogram (ERG) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 24, 2020
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
125 participants (estimated)

Arms

  • Arm: Participants with HIE
  • Arm: Healthy participants

Primary Outcome Measure

To evaluate the correlation between retinal function and neurodevelopmental outcomes [ Time Frame: Through 30 months of life ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Alexandra Lindstrom
[email protected]
Pelin Cengiz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin· Madison, WI

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