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

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:

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

No

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)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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