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

Visual Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865093
• Other study ID #: 5006
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Daniela Ricci, Medical Doctor
• Phone: +393929477842
• Email: d.ricci[@]iapb.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 30, 2027
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	5 years
Secondary	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)).	5 years