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

May 17, 2023 updated by: Ricci Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Study Overview

Status

Recruiting

Conditions

Visual Impairment

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daniela Ricci, Medical Doctor
Phone Number: +393929477842
Email: d.ricci@iapb.it

Study Locations

Italy
- - Rome, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Gemelli
    - Contact:
      
      Daniela Ricci
      
      Phone Number: +393929477842
      
      Email: d.ricci@iapb.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Children at risk for visual impairment due to brain lesion, brain malformation, genetic syndroms, Hypoxic Hischemic Encephalopathy, metabolic diseases or ocular pathologies, assessed at neonatal age and followed up to 36 months of age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)).	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

June 30, 2027

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)