VIPPSTAR-G1 Digital Early Intervention for Visual Impairment (VIPPSTAR-G1)

July 16, 2026 updated by: Jessica Galli, Università degli Studi di Brescia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The VIPPSTAR-G1 study is a multicenter, multinational clinical trial evaluating a caregiver-mediated digital early intervention designed to promote visual function and neurodevelopment in infants at risk of or with visual impairment (VI), within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The study is conducted within the framework of the VIPPSTAR Horizon Europe project and integrates telemedicine, digital health technologies, and individualized developmental support into routine clinical care.

Visual function plays a fundamental role in early neurodevelopment. Vision represents the primary means through which infants explore and interact with the environment, while environmental experiences simultaneously shape the maturation and plasticity of visual pathways and broader neurodevelopmental networks. Visual impairment in infancy is therefore associated not only with altered visual functioning but also with increased risk for motor, cognitive, communicative, adaptive, and socio-emotional developmental difficulties.

Visual impairment includes peripheral visual impairment (PVI), caused by ocular or anterior visual pathway disorders, and cerebral visual impairment (CVI), resulting from damage or dysfunction affecting post-geniculate visual pathways and visual cortical networks. These disorders often co-occur. CVI has become one of the leading causes of childhood visual disability in industrialized countries, particularly among infants born preterm or with neonatal neurological complications.

Although early individualized intervention and visually enriched experiences are considered essential to support neuroplasticity and developmental outcomes, implementation of intensive family-centered intervention programs in real-world healthcare systems remains challenging because of limited accessibility, geographic barriers, shortage of specialized services, and socioeconomic constraints affecting families. Digital and telemedicine-based interventions may help overcome these limitations by enabling remote delivery of evidence-based developmental support integrated into everyday family routines.

The VIPPSTAR-G1 protocol evaluates a caregiver-mediated home-based intervention delivered through a dedicated digital platform. The platform provides individualized developmental activities, audiovisual guidance materials, e-learning resources, remote supervision, and continuous communication with clinicians. The intervention is designed to promote naturalistic developmental learning and parent-child interaction within the child's daily environment.

The protocol includes two distinct study populations conducted under a shared methodological framework:

Study Sample 1 - Randomized Controlled Trial Cohort It constitutes the definitive randomized controlled trial (RCT) component of the protocol. This cohort includes 102 newborns at risk of visual impairment recruited from Neonatal Intensive Care Units (NICUs), nurseries, and neuropsychiatry outpatient clinics across participating sites in Italy, Belgium, and Moldova.

Eligible infants are randomized in a 1:1 ratio to: the VIPPSTAR caregiver-mediated digital intervention plus standard care, or standard clinical care alone. Randomization is stratified by recruitment site and biological sex using computer-generated permuted blocks implemented through the REDCap randomization module.

The primary objective of the RCT cohort is to evaluate the efficacy of the intervention in improving: 1)visual acuity, and 2)smooth pursuit eye movements.

Secondary objectives include assessment of: visual processing speed and ocular motor functioning through gaze metrics and qualitative assessments, developmental quotient, adaptive behavior, language development, everyday visual-related behavior, parental stress, quality of life, feasibility, acceptability and usability of the intervention. Primary confirmatory efficacy analyses will be conducted exclusively in Study Sample 1.

Study Sample 2 - Exploratory Pilot Cohort It is an additional exploratory pilot subgroup including 48 infants and toddlers up to 42 months of age with established peripheral or cerebral visual impairment or both.

The objective of this cohort is to evaluate: feasibility, acceptability, usability, adherence, implementation procedures, and preliminary clinical effects of the intervention in a broader clinical population beyond neonates at risk of visual impairment.

Participants in the pilot subgroup follow the same assessment and intervention framework and assessment schedule used in the main RCT cohort. However, this exploratory cohort is not powered for confirmatory efficacy analyses. Data derived from this subgroup will primarily be analyzed descriptively and used to inform future refinement and scalability of the intervention model.

Intervention Description The intervention is a non-pharmacological, non-invasive, caregiver-mediated developmental program delivered remotely through the VIPPSTAR digital platform over a 6-months period.

The platform includes: individualized developmental activities, video demonstrations, audio instructions, e-learning educational materials, secure communication systems, weekly online supervision sessions with clinicians, monitoring tools for adherence and feasibility.

Activities are personalized according to each child's developmental profile, visual functioning, and clinical needs, and are integrated into everyday family routines such as play, caregiving interactions, and home activities.

Clinicians monitor intervention delivery through the digital platform and adapt activities over time according to child responses and caregiver feedback.

Participants allocated to the control group receive standard clinical care according to local institutional practice, including routine follow-up visits and access to clinical communication channels when needed.

Study Timeline and Assessments Participants undergo evaluations at: baseline before randomization (T0), post-intervention after 24 weeks (T1), 6-month follow-up after intervention completion (T2).

Assessments include: neuro-ophthalmological evaluation including ophthalmological assessment and basic visual functions/ocular motor function evaluation; visual processing speed/ eye-tracking based ocularmotor parameters, developmental testing including the assessment of developmental quotient, adaptive behavior assessment, language assessment, parental stress questionnaires, quality-of-life measures, feasibility, acceptability and usability measures.

Outcome assessors and statisticians remain blinded to treatment allocation whenever feasible.

Outcomes

The co-primary outcomes for the RCT cohort are:

Change improvement of visual acuity Change in smooth pursuit function

Secondary outcomes evaluate broader neurodevelopmental, neuro-ophthalmological parameters, adaptive behavior, parental stress, quality of life, and feasibility of the digital intervention.

Data Management and Data Sharing Study data are collected and managed through a centralized REDCap platform hosted at the University of Brescia. All data are pseudo-anonymized and handled in compliance with GDPR and applicable national regulations.

De-identified individual participant data (IPD) underlying published study results may be shared upon reasonable request after publication of the primary analyses. Statistical code, metadata, and data dictionaries may also be shared for academic, non-commercial research purposes.

In preparation for multicenter data exchange and digital platform implementation, the consortium is establishing the necessary Data Sharing Agreements, Data Processing Agreements, and software governance procedures among participating institutions and technology providers to ensure secure, compliant, and ethically governed handling of study data.

Ethical Considerations The study has received ethics approval from Comitato Etico Territoriale Lombardia 6 (Approval No. VIPPSTAR G1 - NP 6758; approved 4th June 2026). Written informed consent is obtained from parents or legal guardians before participation.

Given the non-invasive and caregiver-mediated nature of the intervention, the study is considered minimal risk. Safety monitoring procedures are implemented throughout the study period, including systematic monitoring of adverse events, participant burden, and intervention tolerability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Katholieke Universiteit Leuven
        • Contact:
        • Sub-Investigator:
          • Lauren Billestraet, Dr
  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • ASST Spedali Civili di Brescia
        • Contact:
        • Contact:
          • Lucrezia Maria Visconti, Dr
          • Phone Number: 00390303995724
        • Sub-Investigator:
          • Nicole D'Adda, Dr
        • Sub-Investigator:
          • Anna Alessandrini, Dr
        • Sub-Investigator:
          • Laura Dusi, Dr
        • Sub-Investigator:
          • Elisa Maria Fazzi, Prof
      • Brescia, BS, Italy, 25123
        • University of Brescia
        • Sub-Investigator:
          • Laura Dusi, Dr
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Erika Loi, Dr
        • Sub-Investigator:
          • Lucrezia Maria Visconti, Dr
        • Sub-Investigator:
          • Stefano Calza, Prof
        • Sub-Investigator:
          • Elisa Fazzi, Prof
        • Sub-Investigator:
          • Melissa Marras, Dr
      • Pavia, BS, Italy
        • Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation
        • Contact:
        • Sub-Investigator:
          • Sabrina Signorini, Dr
        • Sub-Investigator:
          • Cecilia Naboni, Dr
        • Sub-Investigator:
          • Antonella Luparia, Dr
        • Sub-Investigator:
          • Sonia Trussardi, Dr
        • Sub-Investigator:
          • Benedetta Brafa, Dr
  • Moldova
      • Chisinau, Moldova, MD-2019
        • Centrul Republican de Reabilitare pentru Copii
        • Contact:
        • Sub-Investigator:
          • Amalia Dolinschii, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm
Participants receive a caregiver-mediated, home-based digital intervention delivered through the VIPPSTAR platform, parallel to standard clinical care, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. The intervention includes personalized developmental activities, audiovisual materials, weekly online supervision, and continuous communication with clinicians. It includes participants enrolled in both the main RCT cohort and the exploratory pilot cohort.
Behavioral: 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.
Other: Standard Care Arm
Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual acuity measured in cycles per degree or decimes, using Teller Acuity Cards or Lea Symbols
Time Frame: 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.
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit assessed on an ordinal scale (continuous, discontinuous, difficult to elicit)
Time Frame: 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.
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fixation Stability assessed on an ordinal scale (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)
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)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Fixation Accuracy - eye tracker-based measure
Time Frame: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in fixation accuracy using eye tracker
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit velocity - eye tracker-based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit velocity
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit accuracy - eye tracker-based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit accuracy
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Smooth pursuit number of anticipatory movements - eye tracker based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in smooth pursuit number of anticipatory movements
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Saccadic eye movements
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in saccadic eye movements using a categorial classification: present, normometric with increased latency, dysmetric but with normal latency, dysmetric with increased latency, absent
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Contrast sensitivity
Time Frame: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in the ability to identify targets, expressed as percentage of contrast level
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Binocular visual field
Time Frame: Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Change in the ability to locate targets presented in different areas of the binocular visual field using clinical examination
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Latencies - eye-tracker based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in visual response latency
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Speed - eye-tracker based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes on visual response speed
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Visual Response Accuracy - eye-tracker based measure
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes on visual response accuracy
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Developmental Quotient at Bayley Scales of Infant and Toddler Development - IV edition
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in cognitive, motor and language quotients at Bayley Scales of Infant and Toddler Development-IV
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Developmental Quotient at Reynell Zinkin Scales of visual deficits
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in Developmental Quotient and subquotients at Reynell Zinkin Scales for infants with visual impairment aged 12 months and older (corrected age)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Adaptive Functioning
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in raw scores, total quotient and subquotients at Vineland Adaptive Behavior Scales-III (VABS-III)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Language Development
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the number of understood/spoken words and sentences, changes in the number of gestures as reported at MacArthur-Bates Communicative Development Inventories (MB-CDI) by parents
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Everyday visual-related behaviour questionnaire (Preverbal Visual Assessment - PreViAs)
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the total score and subscores at Preverbal Visual Assessment (PreViAs) questionnaire for infants aged 23 months and younger (corrected age)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Every day visual-related behaviour (CVI Parental Questionnaire)
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in the total score and subscores at CVI Parental Questionnaire for infants aged 24 months and older
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Parental Stress
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in total score and subscores at Parenting Stress Index-4 (PSI-4)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Quality of Life scores
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Changes in total score and subscores at Pediatric Quality of Life Inventory (PedsQL)
Baseline (T0), post-intervention at 24 weeks (T1), and 6-month follow-up (T2)
Digital platform usability
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention usability through System Usability Scale (SUS)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention acceptability
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention acceptability through Acceptability of Intervention Measure (AIM)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention Appropriateness
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention appropriateness through Interventio Appropriateness Measure (IAM)
Baseline (T0), post-intervention at 24 weeks (T1)
Intervention feasibility
Time Frame: Baseline (T0), post-intervention at 24 weeks (T1)
Evaluation of intervention feasibility through Feasibility of Intervention Measures (FIM)
Baseline (T0), post-intervention at 24 weeks (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Università degli Studi di Brescia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Galli, Prof, Unit of Child Neurology and Psychiatry, ASST Spedali Civili of Brescia, Italy - Department of clinical and experimental sciences, University of Brescia, Brescia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIPPSTARG1 - NP 6758
  • Horizon Europe Grant Agreement (Other Grant/Funding Number: European Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in publications, including demographic, clinical, neurodevelopmental, neuro-ophthalmological, eye-tracking, and questionnaire-derived outcome data, will be made available upon reasonable request after publication of the primary study results.

Statistical analysis code may also be shared for academic, non-commercial research purposes.

All data sharing requests will be subject to approval by the Sponsor and compliance with applicable national and European data protection regulations, including GDPR requirements. No directly identifiable participant data will be shared.

In preparation for multicenter data exchange and digital platform use, the study consortium is establishing the necessary Data Sharing Agreements, Data Processing Agreements, and software governance procedures among participating institutions and technology providers to ensure secure, compliant, and ethically governed handling of study data.

IPD Sharing Time Frame

De-identified individual participant data will become available after the end of the trial and will remain available for at least 4 years (art. 16 GA), subject to the abscence of objection from the Vippstar's Granting Authority, to the applicable measures determined within the consortium agreement and DMP and to the applicable data protection regulations.

IPD Sharing Access Criteria

Access to data will be provided to qualified applicants upon reasonable and lawful request, following approval by the Sponsor, the abscence of objection from the Vippstar's Granting Authority and execution of applicable data sharing and data processing agreements in compliance with GDPR and institutional policies. After one year from the end of the trial, access may also be reached according to the Horizon Results Platform's terms and provisions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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