Visual ImpairmentNCT05865093
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
An observational study of Visual Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 2 days to 36 months
- Conditions the study is for
- Visual Impairment
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 36 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Patients at low risk of developing neurological outcomes
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli
Rome, 00168
Daniela Ricci, +393929477842, d.ricci@iapb.it
About this study
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
- Conditions
- Visual Impairment
- Medical subject headings
- Vision Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 5 years
Secondary outcomes (1)
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)).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jul 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricci Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865093
- Sponsor's protocol ID
- 5006
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
- ClinicalTrials.gov ID
- NCT05865093
- Acronym / sponsor ID
- 5006
- Conditions
- Visual Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 2 days to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients at low risk of developing neurological outcomes
- Refusal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)).
1 secondary outcome
Correlation betwwen functional visual assessment score to MRI score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Ricci, Medical Doctor (+393929477842, d.ricci@iapb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.