VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

VIPPSTAR Digital Early Intervention: A caregiver-mediated digital intervention aimed at promoting visual and neurodevelopmental outcomes in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The intervention includes individualized activities integrated into daily family routines and supported through remote supervision and e-learning content.

Standard Clinical Care: Routine clinical care provided according to local healthcare protocols, including follow-up visits and additional evaluations if clinically indicated.Standard intervention protocols according to local healthcare services are allowed.

Study 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.

Eligibility

Primary outcome measure(s)

• Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols — Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
  Assessment of improvement in visual acuity from baseline following the intervention. Primary efficacy analyses will be conducted in Study Sample 1 only. Data from Study Sample 2 will be analyzed descriptively and exploratorily.
• Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit) — Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
  Assessment of changes in smooth pursuit eye movements assessed using a clinical evaluation on an ordinal scale (continuous, discontinuous, difficult to elicit). Primary efficacy analyses will be conducted in Study Sample 1 only. Data from Study Sample 2 will be analyzed descriptively and exploratorily.

Trial sites (5)

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