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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-36
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients at low risk of developing neurological outcomes

Refusal of informed consent

Trial population

Children at risk for visual impairment due to brain lesion, brain malformation, genetic syndroms, Hypoxic Hischemic Encephalopathy, metabolic diseases or ocular pathologies, assessed at neonatal age and followed up to 36 months of age

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

The 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)).

Time frame
5 years

Secondary outcomes

1

Correlation betwwen functional visual assessment score to MRI score

Results 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)).

Time frame
5 years

Other outcomes

Sponsors and contacts

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