MRI Screening for Auditory Pathway Malformations in Visua... | NCT02896738

Studies
MRI Screening for Auditory Pathway Malformations in Visually Impaired Children

NCT02896738

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Apr 20, 2022Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Visual Impairment

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Mar 2, 2022Actual

Completion Date

Apr 12, 2022Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2022

Last Update Posted Date

Apr 20, 2022Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with Auditory Pathway Malformation		baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Visually impaired children undergoing MRI exploration.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louise Boyeldieu, MD	Fondation OPH A de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique Adolphe de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D014786	Vision Disorders

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided