Assessing visual functions in infants at risk of visual impairment

Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study

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
• Enrollment: 700 (estimated)
• Ages: 2 Days to 36 Months
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome)
• Trial ID: NCT05865093 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who are at low risk of developing neurological outcomes or who refuse informed consent may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Rome

• Fondazione Policlinico Gemelli — Rome, Italy (RECRUITING)

Study contacts

• Study coordinator: Daniela Ricci, Medical Doctor

Conditions: Visual Impairment