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.

NCT Number	NCT07717671
Lead Sponsor	Università degli Studi di Brescia Collaborators: ASST Spedali Civili of Brescia, Brescia, Italy, Department of Development and Regeneration, KU Leuven, Leuven, Belgium, Centrul Republican de Reabilitare pentru Copii, Moldova, Vestibular and oculomotor laboratory, Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands, National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy, LIGHT Center, Brescia, Italy, EODYNE SYSTEMS SL, Barcelona, Spain, Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy, Department of Brain and Behavioral Sciences University of Pavia, Pavia, Italy, Child Neurology and Psychiatry Unit IRCCS Mondino Foundation, Pavia, Italy, VIPPSTAR Consortium
Conditions	Visual Impairment, Cerebral Visual Impairment, Neurodevelopmental Disorders, Prematurity
Enrollment	150 participants
Start Date	2026-07-01
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-21