NCT02896738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

6.5 years

First QC Date

September 7, 2016

Last Update Submit

April 13, 2022

Conditions

Visual Impairment

Outcome Measures

Primary Outcomes (1)

  • number of patients with Auditory Pathway Malformation

    baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Visually impaired children undergoing MRI exploration.

You may qualify if:

  • age \< 18 years old
  • visual impairment
  • MRI scheduled to explore their visual impairment
  • parents' informed consent for participation in the study

You may not qualify if:

  • tumoral origin for the visual impairment
  • no health insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Louise Boyeldieu, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

September 1, 2015

Primary Completion

March 2, 2022

Study Completion

April 12, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

FR(1)