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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865093
Enrollment
700
Registered
2023-05-18
Start date
2022-07-01
Completion date
2027-06-30
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Impairment

Brief summary

The aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
2 Days to 36 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study5 yearsThe score of the functional visual assessment will be obtained at neonatal age and at 1-3-6-9-12-18-24-36 months of life will be analysed at each age and compared to neurodevelopment findings using different scales according to age. These results will be related to the MRI total score (obtained by the sum of scores by site: cortex, basal ganglia, white matter and cerebellum, normal (0), mild abnormal (1), severely abnormal (2)).

Secondary

MeasureTime frameDescription
Correlation betwwen functional visual assessment score to MRI score5 yearsResults of functional visual assessment will be related to the MRI total score (obtained by the sum of scores by site: cortex, basal ganglia, white matter and cerebellum, normal (0), mild abnormal (1), severely abnormal (2)).

Countries

Italy

Contacts

Primary ContactDaniela Ricci, Medical Doctor
d.ricci@iapb.it+393929477842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026