Neurodevelopmental Outcomes in Cerebral Visual Impairment

Conditions

• Cerebral Visual Impairment

Eligibility Criteria

Sex

ALL

Age

6 Months - 72 Months

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jul 31, 2025

Status verified

Oct 2025

Primary completion

Aug 31, 2030

Completion

Aug 31, 2031

Study Design

Enrollment

600 participants (estimated)

Arms

• Arm: Screening
  This group will be screened for CVI in the first year of life. Children with positive screens for CVI will undergo a comprehensive CVI evaluation.
• Arm: Neurodevelopment
  Children in this group will participate in a multi-disciplinary CVI clinic as well as neurodevelopmental testing and a neuro-ophthalmic eye exam at baseline and 12 months later.

Primary Outcome Measure

Preverbal Visual Assessment (PreViAs) [ Time Frame: Aim 1: 6, 9, and 12 months of age (corrected age if born preterm) ]

Locations (1)

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