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NCT Number: NCT07275021

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

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.

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Key information

About this study

The study is a prospective observational study designed to follow preterm and term infants who are at high risk for Cerebral/ Cortical Visual Impairment (CVI). Preterm Infants born before 32 weeks gestational age with conditions such germinal matrix/intraventricular hemorrhage (IVH), white matter injury (WMI including periventricular leukomalacia (PVL), and late term and term infants with Hypoxic-Ischemic Encephalopathy (HIE) or prenatal Stroke will be enrolled during the neonatal intensive care unit (NICU) stay and monitored through a structured follow-up schedule. The study focuses on data collection using advanced diagnostic imaging and neurodevelopmental assessments without introducing randomization or experimental interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective Clinical and Neurodevelopmental Data Collection

Other

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.

Primary outcomes

  1. Presence of Cerebral Visual Impairment (CVI) at 24 Months

    Time frame: 24 months of age

    Diagnosis of Cerebral/Cortical Visual Impairment (CVI) based on standardized clinical visual assessment performed.

    Outcome measure: Low, or high risk.

Secondary outcomes

  1. Visual Function assessment

    Time frame: 24 months

    Visual function evaluated using the age-appropriate CVI and parent questionnaire administered at scheduled follow-up intervals (6, 12, and 24 months per protocol), with primary reporting at 24 months.

    • Teller acuity Cards (testing distance: 38 cms, 55 cms 84 cms)
    • Patti Pics or grating acuity (testing distance: 25 cms, 50 cms and 100 cms)
    • Visual behavior scale (grade: 1, 2, or 3)
    • Resolution Distance Visual acuity

    Outcome measure: Low, or high risk.

  2. Visual Evoked Potential (VEP) Response

    Time frame: 24 months

    Assessment of cortical visual pathway response using VEP performed at 6 and 24 months per protocol, with primary reporting at 24 months. Outcome measure: low or high risk group.

  3. Neurodevelopmental Composite Score

    Time frame: 24 months

    Standardized neurodevelopmental testing obtained as part of 12-, 18-, and 24-month clinical follow-up (e.g., Bayley-IV). Primary reporting at 24 months

    Outcome measure:

    • Low-Risk: scores within or above age-expected norms
    • High-Risk: scores ≥1 SD below the mean (Standard Score <85) indicating developmental delay

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed El-Dib

CONTACT

Mohamed El-Dib, MD

CONTACT

[email protected]

+15712016409

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Children's Hospital

Registry information

Official study title

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

Acronym: CVI

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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