Clinical trial Recruiting at 1 site Observational Ages 2 Days to 36 Months

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 typeObservational
Ages2 Days to 36 Months
SexAll
Enrollment700 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Rome)
StatusRecruiting
StartedJuly 1, 2022
Main results expectedSeptember 30, 2023
Study endsJune 30, 2027
Registry record updatedMay 18, 2023
Trial IDNCT05865093 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.