|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 June 2016 |
|
Main ID: |
NCT02529098 |
|
Date of registration:
|
10/06/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
PlainteIMF |
|
Scientific title:
|
Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02529098 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Francois Malecaze, professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Toulouse |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Cataract surgery with an bilateral multifocal lens implant Restor
Symptomatic patients :
- Symptomatic bilateral visual difficulties for 3 months or more after the intervention
which impact the daily activity
Asymptomatic patients :
- No visual complaint for 3 months or more after the intervention
Exclusion Criteria:
- Patients with ophthalmology disorders
- Contra indication for fMRI
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Vision Disorders
|
|
Intervention(s)
|
|
Other: fMRI
|
|
Primary Outcome(s)
|
|
Extent of neural activation in visual cortex measured by the number of voxels
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
extent of neural activation in visual cortex measured by the number of voxels
[Time Frame: 1 day]
|
|
Secondary ID(s)
|
|
12 523 03
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|