Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4 | NCT01215045

Studies
Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4

NCT01215045

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Oct 5, 2010Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Cataract

Interventions

AcrySof ReSTOR Aspheric +4

Countries

United States

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

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Aug 12, 2008

First Submission Date that Met QC Criteria

Oct 4, 2010

First Posted Date

Oct 5, 2010Estimated

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

Oct 4, 2010

Last Update Posted Date

Oct 5, 2010Estimated

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

Description Module

Brief Summary

Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ReSTOR +4		AcrySof ReSTOR Aspheric +4	Device: AcrySof ReSTOR Aspheric +4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AcrySof ReSTOR Aspheric +4	Device	Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)	ReSTOR +4

Measure	Description	Time Frame
Visual Acuity		6 months

Measure	Description	Time Frame
Contrast sensitivity, patient survey		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with cataracts

Exclusion Criteria:

Preexisting conditions confounding results; > 1 Diopter preoperative astigmatism

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Study participants taken from physician's patient pool implanted with the AcrySof ReSTOR +4 Intraocular Lens (IOL)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided