VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

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.

Inclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment * Gestational age ≤32 weeks OR full-term/newborns\>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes) * NAVEG score ≥3 * At least one neurological or neuroimaging abnormality: * 3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings Exclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment * Epileptic encephalopathy * Parents unable to understand local language Inclusion Criteria: Study Sample 2 - Infants/Toddlers With Visual Impairment * Age ≤42 months * Diagnosis of peripheral or cerebral visual impairment * Moderate or severe visual impairment documented by standardized visual acuity testing Exclusion Criteria: Study Sample 2 - Infants/Toddlers With Visual Impairment * Age \>42 months * Refractory epilepsy or epileptic encephalopathy * Participation in another interventional study within previous 12 months * Parents unable to understand local language