Neurodevelopmental Outcomes in Cerebral Visual Impairment

Официальное название

Integrative Neurodevelopmental Approach to Cerebral Vision Impairment (CVI): Screening and Subtyping in Early Childhood

Обзор

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) establish a novel and easy to use CVI screening algorithm for infants and (2) develop CVI subtypes based on vision, motor, language, and cognition. The overarching goal is to identify CVI early and enhance our comprehension of CVI's impact on a child's development. The results will fundamentally change the approach to designing treatments for children with CVI.

Подробное описание

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 identification is critical for optimal development. Vision is essential in incidental and intentional learning used to build foundational motor, language, and cognitive skills. The proposed research aims to (1) develop a screening algorithm for early detection of CVI and (2) establish neurodevelopmental profiles that will inform intervention for children diagnosed with CVI. The overarching hypothesis is that early detection of CVI and understanding the relationship between visual impairment and neurodevelopment are imperative for creating interventions to optimize a child's abilities. In the first aim, a novel screening algorithm for CVI detection in infants will be tested at three time points between 4-12 months corrected age. In the second aim, an interdisciplinary standardized assessment protocol will be utilized, including visual and developmental evaluations at two time points to create neurodevelopmental subtypes in young children with CVI. This proposal will be implemented by an interdisciplinary research team with a well-established track record of clinical practice and research in CVI. This innovative proposal will lead to a paradigm shift in the current approach to CVI management in young children. The findings from this study will lead to the development of a screening protocol for early detection of CVI that can be easily incorporated into medical practice by providers who routinely interact with young infants and, in time, become standard practice. Additionally, the established neurodevelopmental profiles will serve as the cornerstone for creating comprehensive clinical protocols guiding the care and treatment of children diagnosed with CVI.

Первичные конечные точки

• Preverbal Visual Assessment (PreViAs) [Срок оценки: Aim 1: 6, 9, and 12 months of age (corrected age if born preterm)]
• Visual Acuity [Срок оценки: Aim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later]
• Contrast sensitivity [Срок оценки: Aim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later.]
• Visual Fields [Срок оценки: Aim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later]
• Color Vision [Срок оценки: Aim 2: At enrollment (baseline) and 12 months later]
• Eye Motility [Срок оценки: Aim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later]
• Objects in motion [Срок оценки: Aim 1: If/when visual concern are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later]
• Accomodation [Срок оценки: Aim 1: If/when visual concerns are indicated on the Preverbal Visual Assessment (PreViAs) screening tool and/or at 12 months of age (corrected if preterm); Aim 2: At enrollment (baseline) and 12 months later.]
• Stereo Acuity [Срок оценки: Aim 2: At enrollment (baseline) and 12 months later]
• Hemispatial neglect [Срок оценки: Aim 2: At enrollment (baseline) and 12 months later]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT07212010 · 2024-0772 · R01EY036154-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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