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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865093
Collaborator
(none)
700
Enrollment
1
Location
60
Anticipated Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2027

    Outcome Measures

    Primary Outcome Measures

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

    1. Correlation betwwen functional visual assessment score to MRI score [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)).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Days to 36 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Gemelli Rome Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ricci Daniela, Principal Investigator Pediatric Neurologist, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05865093
    Other Study ID Numbers:
    • 5006
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vision Disorders
    Vision, Low

    Study Results

    No Results Posted as of May 18, 2023