CVI
The Vision Study: Cerebral/ Cortical Visual Impairment (CVI)
Sponsor study identifier
observational
60
1 country
1
Study Start
July 7, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2025
Actual (reported)August 19, 2025
Actual (reported)December 10, 2025
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Presence of Cerebral Visual Impairment (CVI) at 24 Months
Diagnosis of Cerebral/Cortical Visual Impairment (CVI) based on standardized clinical visual assessment performed. Outcome measure: Low, or high risk.
24 months of age
Visual Function assessment
24 months
Visual Evoked Potential (VEP) Response
24 months
Infants at high risk for Cerebral/Cortical Visual Impairment (CVI), including preterm infants with IVH or white matter injury, term or late preterm infants with hypoxic-ischemic encephalopathy (HIE), and infants with perinatal stroke. Participants are followed prospectively and undergo standardized clinical, neuroimaging, neurophysiologic, and developmental assessments through 24 months of age.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population includes preterm and term infants at high risk for cerebral visual impairment due to neurological injury diagnosed in the neonatal period. This includes: * Preterm infants born \<32 weeks gestation with intraventricular hemorrhage or white matter injury * Late preterm (34-36 weeks) and term (37-42 weeks) infants with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia or diagnosed with perinatal stroke Eligible infants are enrolled during their initial hospitalization and followed longitudinally into early childhood to assess visual development, neurodevelopmental outcomes, and early signs of cerebral visual impairment. Parent(s) or legal guardian(s) must be willing and able to provide informed consent.
Brigham and Women's Hospital, and Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Chang MY, Borchert MS. Advances in the evaluation and management of cortical/cerebral visual impairment in children. Surv Ophthalmol. 2020 Nov-Dec;65(6):708-724. doi: 10.1016/j.survophthal.2020.03.001. Epub 2020 Mar 19.
Pilling RF, Allen L, Bowman R, Ravenscroft J, Saunders KJ, Williams C. Clinical assessment, investigation, diagnosis and initial management of cerebral visual impairment: a consensus practice guide. Eye (Lond). 2023 Jul;37(10):1958-1965. doi: 10.1038/s41433-022-02261-6. Epub 2022 Oct 18.
Mohamed El-Dib, MD
Brigham and Women's Hospital
Mohamed El-Dib
CONTACT
First Submitted
August 19, 2025
First Posted
December 10, 2025
Study Start
July 7, 2025
Actual (reported)Primary Completion
Neurodevelopmental Composite Score
24 months
Contact the study team to confirm eligibility.
Sakki HEA, Dale NJ, Sargent J, Perez-Roche T, Bowman R. Is there consensus in defining childhood cerebral visual impairment? A systematic review of terminology and definitions. Br J Ophthalmol. 2018 Apr;102(4):424-432. doi: 10.1136/bjophthalmol-2017-310694. Epub 2017 Nov 16.
December 31, 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 10, 2025
Record last verified: 2025-08
No plan to share individual participant data
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Source: ClinicalTrials.gov.
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