Actively Recruiting
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-05-18
700
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying early visual function in infants who may develop cerebral visual impairment due to brain or eye-related problems. The study focuses on babies from neonatal age up to 36 months old who are at risk because of conditions like brain lesions or ocular diseases. This pilot study aims to better understand how vision develops in these young patients over time. The study observes infants without testing any treatments or interventions. Researchers will assess visual abilities and correlate these findings with brain MRI results to understand the relationship between brain structure and vision function. Participants will be followed and evaluated regularly over a period of five years to track their visual development and neurological status. During the study, infants will undergo visual function assessments and brain imaging evaluations. The researchers will collect data on visual performance scores and compare them with MRI results to better understand visual impairment risks. The total participation includes assessments up to 36 months of age, with long-term follow-up planned for five years to monitor outcomes and correlations between visual function and brain health.
CONDITIONS
Brief Title
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age
- Diagnosis of genetic syndromes
- Diagnosis of hypoxic ischemic encephalopathy
- Presence of brain malformations
- Diagnosis of metabolic diseases
- Presence of ocular pathologies
You will not qualify if you...
- Patients at low risk of developing neurological outcomes
- Refusal of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to assess early visual functions and correlate functional visual assessment with MRI scores.
Regular visits over 5 years
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli
Rome, Italy, 00168
Actively Recruiting
Research Team
D
Daniela Ricci, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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