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

Recruiting

• Conditions: Visual Impairment

• Registration Number: NCT05865093
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-17
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18
• Primary Completion: 2023-09-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

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Exclusion Criteria

• Patients at low risk of developing neurological outcomes
• Refusal of informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)).

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy