VIPPSTAR-G1 Digital Early Intervention for Visual Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-42
SponsorUniversità degli Studi di Brescia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Gestational age ≤32 weeks OR full-term/newborns>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes)
NAVEG score ≥3
3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings
Disqualifiers
Epileptic encephalopathy
Parents unable to understand local language
Age ≤42 months
Diagnosis of peripheral or cerebral visual impairment
Trial design
Design model
Parallel
Treatments tested in this trial
VIPPSTAR Digital Early Intervention
BehavioralA 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
Other interventionRoutine 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Standard Care ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
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.
Time frame
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)2
Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit)
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.
Time frame
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)Secondary outcomes
1
Fixation Stability assessed on an ordinal scale (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)
Evaluation of changes in fixation stability using clinical examination (stable for more than 3s, unstable for less than 3 s, difficult to evoke, not elicited)
Time frame
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)2
Fixation Accuracy - eye tracker-based measure
Change in fixation accuracy using eye tracker
Time frame
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)3
Smooth pursuit velocity - eye tracker-based measure
Change in smooth pursuit velocity
Time frame
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)4
Smooth pursuit accuracy - eye tracker-based measure
Change in smooth pursuit accuracy
Time frame
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)Sponsors and contacts
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Università degli Studi di Brescia
Lead sponsor
ASST Spedali Civili of Brescia, Brescia, Italy
Collaborator
Department of Development and Regeneration, KU Leuven, Leuven, Belgium
Collaborator
Centrul Republican de Reabilitare pentru Copii, Moldova
Collaborator
Vestibular and oculomotor laboratory, Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands
Collaborator
National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy
Collaborator
LIGHT Center, Brescia, Italy
Collaborator
EODYNE SYSTEMS SL, Barcelona, Spain
Collaborator
Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy
Collaborator
Department of Brain and Behavioral Sciences University of Pavia, Pavia, Italy
Collaborator
Child Neurology and Psychiatry Unit IRCCS Mondino Foundation, Pavia, Italy
Collaborator
VIPPSTAR Consortium
Collaborator
Source ClinicalTrials.gov
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