NCT07212010

Neurodevelopmental Outcomes in Cerebral Visual Impairment

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Months – 72 Months
• Healthy volunteers: Accepted

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) 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.

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 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.

Conditions

• Cerebral Visual Impairment

Timeline

• Start date: 2025-07-31
• Primary completion: 2030-08-01
• Completion: 2031-08-01
• First posted: 2025-10-08
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States