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NCT Number: NCT05865093

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

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

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Key information

Conditions

Visual Impairment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

2 day–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 5 years

    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)).

Secondary outcomes

  1. Correlation betwwen functional visual assessment score to MRI score

    Time frame: 5 years

    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)).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Ricci, Medical Doctor

CONTACT

[email protected]

+393929477842

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
May 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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