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Recruiting NCT05865093

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

— Observational Visual Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Visual Impairment. Basic parameters: 2 Days — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study [Time frame: 5 years]
Secondary outcome measures (1)
  • Correlation betwwen functional visual assessment score to MRI score [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Gemelli — Rome

Identifiers

NCT: NCT05865093 · 5006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗