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NCT02529098 Clinical Trial

Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

Vision Disorders Clinical Trial

— PlainteIMF  

Official title:
Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02529098
Other study ID # 12 523 03
Secondary ID
Status Withdrawn
Phase N/A
First received June 10, 2015
Last updated May 27, 2016
Start date June 2015
Est. completion date July 2016

Study information
Verified date May 2016
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• fMRI
functional magnetic resonance imaging

Locations
Country Name City State
France UHToulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Extent of neural activation in visual cortex measured by the number of voxels compare the extent of neural activation in visual cortex between groups 1 day No
Secondary extent of neural activation in visual cortex measured by the number of voxels compare the extent of neural activation in the different area visual cortex between groups 1 day No
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