Safety and Effectiveness of the Akreos Toric Intraocular... | NCT00825513

Studies
Safety and Effectiveness of the Akreos Toric Intraocular Lens.

NCT00825513

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Mar 25, 2013Estimated

Enrollment

198Actual

Phase

Phase 4

Conditions

Cataract
Astigmatism

Interventions

Akreos Toric IOL
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Countries

Sweden

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

Mar 2013

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

Feb 2009

Primary Completion Date

Mar 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 21, 2009Estimated

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

Mar 19, 2013

Certification/Extension First Submitted that Passed QC Review

Mar 19, 2013

Certification/Extension First Posted Date

Mar 25, 2013Estimated

Last Update Submitted Date

Mar 19, 2013

Last Update Posted Date

Mar 25, 2013Estimated

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

The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Detailed Description

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Akreos Toric	Experimental	Akreos Toric Intraocular Lens	Device: Akreos Toric IOL
Akreos Advanced	Active Comparator	Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)	Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Akreos Toric IOL	Device	Lens implant following cataract surgery	Akreos Toric

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.		32 months

Secondary Outcomes

Measure	Description	Time Frame
Lens misalignment as determined by postoperative manifest refraction and vector analysis.		32 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
Subjects must require a lens power from 15 to 30 diopters.

Exclusion Criteria:

Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with corneal pathology potentially affecting topography.

Accepts Healthy Volunteers

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
Gabriele Brenger	Bausch & Lomb Incorporated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital		Umeå		SE-901 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D001251	Astigmatism

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided