Status:
ENROLLING_BY_INVITATION
Neurodevelopmental Outcomes in Cerebral Visual Impairment
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Cerebral Visual Impairment
Eligibility:
All Genders
6-72 years
Brief Summary
Cerebral visual impairment (CVI) is one of the leading causes of pediatric visual impairment and negatively impacts the development of motor, language, and cognitive skills. This study proposes to (1)...
Detailed Description
Cerebral visual impairment (CVI) is the leading cause of visual impairment in children. Although the onset is typically early in life, diagnosis is often delayed until preschool age or later. Early id...
Eligibility Criteria
Inclusion
- Aim 1 (CVI Risk Group): Infants 8 months of age and who meet any of the following:
- The presence of any of the following comorbid diagnoses (CVI risk criteria): brain injury, hypoxia/ischemia, congenital structural abnormalities of the brain, genetic syndromes, epilepsy, infantile spasms/seizures, central nervous system infection, intrauterine drug/alcohol exposure, brain volume loss, or periventricular leukomalacia.
- Presence of any of the following abnormal neuro-imaging findings (CVI risk criteria): Vascular insults, underlying genetic/structural/migrational abnormality, brain atrophy, prematurity sequelae, hydrocephalus, presumed metabolic findings, presumed infection findings.
- Aim 1: (control group): Infants less than 8 months of age negative for CVI risk criteria (see above).
Exclusion
- Aim 1: (both groups): Known visually impairing conditions of the eyes and optic nerves (e.g., inherited retinal diseases, bilateral moderate-to-severe optic nerve hypoplasia), cataracts, retinopathy of prematurity with significant visual sequelae (e.g. macular ectopia or retinal detachment) will be excluded from the study to ensure CVI is the primary cause of a positive PreViAs screen.
- Aim 2: Inclusion criteria:
- Children 12-\< 60 months of age
- Confirmed diagnosis of CVI
- Children must meet at least 1 of these 2 criteria to confirm the diagnosis of CVI during a CVI clinic visit: I: (1) the presence of visual function impairment (e.g., visual acuity) not attributed to anterior visual pathway abnormalities (except mild optic atrophy) or 2) evidence of visual perception/functional vision deficit.
- Aim 2:
Key Trial Info
Start Date :
July 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT07212010
Start Date
July 31 2025
End Date
August 1 2031
Last Update
October 9 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229