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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn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• Status: Withdrawn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

• Vision Disorders

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