Groundbreaking study could unlock early detection of vision issues in infants
NCT ID NCT07212010
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is working to create a simple screening test to find cerebral vision impairment (CVI) in babies and young children. CVI is a leading cause of vision problems in kids, often linked to brain injuries or conditions. Researchers will study 600 children to better understand how CVI affects vision, movement, and learning, with the goal of helping kids get the right support early.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Aim 1: (at risk group) Children with medical and neuroimaging conditions that put children at high risk for cerebral visual impairment (control group) age matched peers without high-risk medical and neuroimaging conditions. Aim 2: Children with a diagnosis of cerebral visual impairment confirmed by a CVI multidisciplinary team visit.
- Ages
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6 to 72 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: 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: Exclusion Criteria: * Children with autism spectrum disorder * Children with ocular conditions including inherited retinal diseases, congenital cataracts, anterior segment dysgenesis, optic nerve hypoplasia, and retinopathy of prematurity with profound visual impairment due to anatomical abnormalities * A chart review will take place to review for exclusion criteria. Children who are identified with one of these potential exclusion criteria will be formally evaluated/screened through a neuro-ophthalmology exam to confirm the presence or absence of the exclusionary diagnoses in the chart. This will occur prior to consenting and/or scheduling any other testing.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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