Visual ImpairmentDIMAVENCT02896738
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children
An observational study of Visual Impairment, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Visual Impairment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 12 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Visually impaired children undergoing MRI exploration.
Who may be able to join
- age < 18 years old
- visual impairment
- MRI scheduled to explore their visual impairment
- parents' informed consent for participation in the study
Who cannot join
- tumoral origin for the visual impairment
- no health insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.
- 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.
number of patients with Auditory Pathway Malformation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2015
- Primary completion2 Mar 2022
- Study completion12 Apr 2022
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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Louise Boyeldieu, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896738
- Sponsor's protocol ID
- LBU_2015_6
- Acronym
- DIMAVE
- Status last verified
- Apr 2022
- First submitted
- 7 Sep 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Screening for Auditory Pathway Malformations in Visually Impaired Children
- ClinicalTrials.gov ID
- NCT02896738
- Acronym / sponsor ID
- DIMAVE / LBU_2015_6
- Conditions
- Visual Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Sep 2015 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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.
This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Visually impaired children undergoing MRI exploration.
Key inclusion criteria (4 listed)
- age < 18 years old
- visual impairment
- MRI scheduled to explore their visual impairment
- parents' informed consent for participation in the study
Key exclusion criteria (2 listed)
- tumoral origin for the visual impairment
- no health insurance coverage
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
number of patients with Auditory Pathway Malformation
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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. This study is not recruiting at the moment.
Louise Boyeldieu, MD principal investigator
Fondation OPH A de Rothschild
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 Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 20 Apr 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with Auditory Pathway Malformation (time frame: baseline). 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 20 Apr 2022.