Assessing visual functions in infants at risk of visual impairment
Official title: Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05865093 · Data updated 2026-11-12
This study is testing how well infants at risk of vision problems can see as they grow, to help find early signs of visual impairment and guide future support for them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Days to 36 Months |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | September 30, 2023 |
| Study ends | June 30, 2027 |
| Registry record updated | May 18, 2023 |
| Trial ID | NCT05865093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged between 34 weeks of post-menstrual age and 36 months who were born prematurely or have specific medical conditions such as genetic syndromes, hypoxic-ischemic encephalopathy, brain malformations, metabolic diseases, or ocular pathologies.
✕Probably not a fit
Patients who are at low risk of developing neurological outcomes or who refuse informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate visual function in infants from neonatal age up to 36 months who are at risk of developing visual impairment due to brain lesions or ocular pathologies. The study will monitor these infants to identify early signs of visual impairment and understand the progression of their visual capabilities. By focusing on a specific age group and risk factors, the study seeks to gather valuable data that could inform future interventions and support for affected children.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention strategies for infants at risk of visual impairment, potentially improving their visual outcomes.
How similar studies have gone: While this study focuses on a specific population, similar observational studies have shown success in identifying early visual impairments in at-risk infants, suggesting that this approach is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age * Genetic syndroms * Hypoxic Hischemic Encephalopathy * Brain malformation * Metabolic diseases * Ocular pathologies Exclusion Criteria: * Patients at low risk of developing neurological outcomes * Refusal of informed consent
Where it's running
-
Fondazione Policlinico Gemelli
Rome, Italy Recruiting
Study contacts
- Study coordinator: Daniela Ricci, Medical Doctor
- Email: d.ricci@iapb.it
- Phone: +393929477842
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.