Clinical Research Directory

VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

Sponsor: Università degli Studi di Brescia

Summary

Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental outcomes, but implementation of intensive interventions in routine clinical practice remains challenging. The VIPPSTAR-G1 study evaluates a caregiver-mediated digital intervention delivered through a dedicated platform designed to support visual and neurodevelopmental functions in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. This multicenter, multinational, single-blind randomized controlled trial will enroll 102 newborns at risk of visual impairment and an additional exploratory pilot subgroup of 48 infants and toddlers with established visual impairment. Participants will be randomized to receive either the VIPPSTAR digital intervention plus standard care or standard care alone. Outcomes include visual acuity, smooth pursuit, additional neuro-ophthalmological functions, neurodevelopmental measures, adaptive functioning, language development, parental stress, quality of life, and feasibility of the digital intervention.

Official title: VIPPSTAR-G1: A Multicenter Randomized Controlled Trial Evaluating a Caregiver-mediated Digital Intervention to Promote Visual Function and Neurodevelopment in Infants at Risk of/With Visual Impairment

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Interventions

Locations (5)