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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02529098
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vision Disorders	Other: fMRI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation
• Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: asymptomatic patients fMRI Asymptomatic patients	Other: fMRI; functional magnetic resonance imaging
Experimental: symptomatic patients fMRI patients with visual difficulties	Other: fMRI; functional magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

1. Extent of neural activation in visual cortex measured by the number of voxels [1 day]

   compare the extent of neural activation in visual cortex between groups

Secondary Outcome Measures

1. extent of neural activation in visual cortex measured by the number of voxels [1 day]

   compare the extent of neural activation in the different area visual cortex between groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHToulouse	Toulouse		France	31000

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Francois Malecaze, professor, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02529098
• Other Study ID Numbers: 12 523 03
• First Posted: Aug 19, 2015
• Last Update Posted: Jun 1, 2016
• Last Verified: May 1, 2016

• Keywords provided by University Hospital, Toulouse: functional magnetic resonance imaging; Lens implantation; pseudophakia
• Additional relevant MeSH terms: Vision Disorders

Study Results

No Results Posted as of Jun 1, 2016