RecruitingNCT07275021

Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates

The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)


Sponsor

Brigham and Women's Hospital

Enrollment

60 participants

Start Date

Jul 7, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries. CVI is a brain-based visual disorder in which visual acuity or visual fields are reduced despite a normal eye examination or greater-than-expected visual impairment relative to ocular pathology. CVI is increasingly recognized in children with neurological conditions, yet it often remains undiagnosed until later childhood, delaying opportunities for early intervention. Population-based studies suggest that CVI is more common than previously understood. Recent estimates indicate that over 180,000 individuals in the United States aged 0-22 years may have diagnosed or likely CVI, with only a minority formally identified. Children with CVI frequently have co-occurring neurological conditions, including cerebral palsy, epilepsy, developmental delays, or genetic disorders. Infants born preterm or with conditions such as hypoxic-ischemic encephalopathy (HIE), perinatal stroke, or white matter injury are at particularly high risk. Prospective research also shows that a substantial proportion of infants born very preterm exhibit behavioral features of CVI later in childhood. Despite improvements in neonatal neurocritical care, early detection of CVI remains challenging. Current clinical practice focuses on managing conditions such as HIE, perinatal stroke, periventricular leukomalacia, and other brain injuries, but there is limited research evaluating structured early identification pathways for CVI in infancy. Diagnostic tools such as brain MRI and Visual Evoked Potentials (VEP) have shown potential for identifying brain-based visual dysfunction, but their integration into early predictive models for CVI has not been fully explored. This study addresses a critical gap in pediatric care by prospectively evaluating high-risk neonates using clinical, neuroimaging, neurophysiologic, and standardized developmental assessments through 24 months of age. Early identification of CVI may support timely referral for visual rehabilitation and developmental services, potentially improving long-term functional outcomes. Developing a predictive model for early CVI detection will contribute to improved clinical pathways, enhance early diagnosis, and reduce the long-term educational and social burden associated with undetected CVI. Ultimately, this research aims to improve outcomes and quality of life for infants at risk for brain-based visual impairment.


Eligibility

Min Age: 31 WeeksMax Age: 42 Weeks

Inclusion Criteria7

  • Preterm infants born \< 32 weeks gestational age with any of the following:
  • Germinal matrix/intraventricular hemorrhage (IVH)
  • White matter injury (WMI), including periventricular leukomalacia (PVL)
  • Late preterm infants (born 34-36 weeks gestation) or term infants (born 37-42 weeks gestation) with:
  • Neonatal encephalopathy treated with therapeutic hypothermia for suspected hypoxic-ischemic encephalopathy (HIE)
  • Infants diagnosed with perinatal stroke
  • Parent(s) or legal guardian(s) willing and able to provide informed consent

Exclusion Criteria1

  • Neonates whose parent(s) or guardian(s) cannot commit to long-term follow-up

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Interventions

OTHERProspective Clinical and Neurodevelopmental Data Collection

Participants undergo standardized collection of clinical, neuroimaging, neurophysiologic, visual assessment and neurodevelopmental data as part of this prospective observational study. Data include information obtained from clinical care and scheduled follow-up assessments through 24 months of age. No interventions are assigned.


Locations(1)

Brigham and Women's Hospital, and Boston Children's Hospital

Boston, Massachusetts, United States

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NCT07275021