- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896738
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children (DIMAVE)
April 13, 2022 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
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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
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Visually impaired children undergoing MRI exploration.
Description
Inclusion Criteria:
- age < 18 years old
- visual impairment
- MRI scheduled to explore their visual impairment
- parents' informed consent for participation in the study
Exclusion Criteria:
- tumoral origin for the visual impairment
- no health insurance coverage
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 |
Time Frame |
|---|---|
|
number of patients with Auditory Pathway Malformation
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louise Boyeldieu, MD, Fondation OPH A de Rothschild
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)
September 1, 2015
Primary Completion (ACTUAL)
March 2, 2022
Study Completion (ACTUAL)
April 12, 2022
Study Registration Dates
First Submitted
September 7, 2016
First Submitted That Met QC Criteria
September 7, 2016
First Posted (ESTIMATE)
September 12, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBU_2015_6
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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