Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

This study is currently recruiting participants.

Verified by Bausch & Lomb, Inc., December 2008

First Received: December 8, 2008 No Changes Posted

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00804726

Purpose

The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens. Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.

Condition	Intervention
Cataract	Device: Akreos MI Five-O IOL

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open-Label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Distance visual acuity. Near visual acuity. Intermediate visual acuity. Near visual acuity with distance best correction. Predictability of refractive outcomes. Incidence of adverse events. [ Time Frame: 420 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best corrected near visual acuity. Intermediate visual acuity with distance best correction. Subjective near point of accommodation (push down test). [ Time Frame: 420 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Akreos MI Five-O IOL	Device: Akreos MI Five-O IOL Phacoemulsification and Akreos MI Five-O IOL surgical implantation

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have a clinically documented diagnosis of age-related cataract.
Subjects must have clear intraocular media other than cataract.
Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion Criteria:

Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with diagnosis of degenerative visual disorder.
Subjects who have any inflammation or edema (swelling) of the cornea.
Subjects with immunodeficiency disorders.
Subjects who have had previous intraocular surgery in the study eye.
Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
Subjects with chronic use of systemic steroids or immunosuppressive medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804726

Contacts

Contact: Ute Kuchinke-Kiehn, PhD

+49-30-800973616

ute.kuchinke-kiehn@bausch.com

Locations

Germany
Augenzentrum Maus Wolfsstr 16	Recruiting
Koln, Germany, 50667
Contact 0221-860-160
Principal Investigator: Matthias Maus, MD

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Helmut Allmeier, PhD

Bausch & Lomb Incorporated

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated ( Keith Edwards )
Study ID Numbers:	580
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00804726 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009