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

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

Who can join

31 Weeks – 42 Weeks · All sexes

Inclusion Criteria:

* 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 Criteria:

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

About the study

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.

What is being tested

• Prospective Clinical and Neurodevelopmental Data Collection (other)

Sponsor: Brigham and Women's Hospital · Participants: 60 · Started: Jul 7, 2025

Contact the study team

• Mohamed El-Dib, MD · Phone: +15712016409

Official record on ClinicalTrials.gov — NCT07275021

Locations in the U.S.

Conditions

• Vision Impairment and Blindness
• Brain Injuries
• Brain Hypoxia-Ischemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.