Evaluation of the Safety & Effectiveness of the Bausch &... | NCT00838045

Studies
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

NCT00838045

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Dec 9, 2011Estimated

Enrollment

125Actual

Phase

Phase 4

Conditions

Cataract
Aphakia

Interventions

The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

Countries

Germany

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

Dec 2011

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

Sep 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2011

Last Update Posted Date

Dec 9, 2011Estimated

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Akreos TL intraocular lens	Experimental	Bausch & Lomb Akreos TL intraocular lens	Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL	Device	Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bast Corrected Visual Acuity	best-corrected visual acuity (BCVA)	24 months

Secondary Outcomes

Measure	Description	Time Frame
Uncorrected Visual Acuity		24 months
Manifest Refraction	mean manifest refraction	24 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Subjects must require a lens power from 15 to 30 diopters.
Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion Criteria:

Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with any inflammation or edema (swelling) of the cornea.
Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
Subjects with previous retinal detachment.
Subjects with diabetic retinopathy (proliferative or non-proliferative).
Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
Subjects who have already received an Akreos TL IOL in the fellow eye.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

ID	Term
D002386	Cataract
D001035	Aphakia