Modification in Cortical Activation in Pseudophakic Patie... | NCT02529098

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

NCT02529098

Sponsor

University Hospital, Toulouse

Status

Withdrawn

Last Update Posted

Jun 1, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vision Disorders

Interventions

fMRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

default recruitment

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Jun 10, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2016

Last Update Posted Date

Jun 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
asymptomatic patients	Sham Comparator	fMRI Asymptomatic patients	Other: fMRI
symptomatic patients	Experimental	fMRI patients with visual difficulties	Other: fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI	Other	functional magnetic resonance imaging	asymptomatic patients symptomatic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francois Malecaze, professor	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHToulouse		Toulouse		31000	France

Condition Browse Module

MeSH Terms

ID	Term
D014786	Vision Disorders
D019591	Pseudophakia

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided