Safety and Effectiveness of the Akreos Toric Intraocular Lens.

This study is currently recruiting participants.

Verified by Bausch & Lomb, Inc., January 2009

First Received: January 16, 2009 No Changes Posted

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00825513

Purpose

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

Condition	Intervention	Phase
Cataract Astigmatism	Device: Akreos Toric IOL Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)	Phase IV

MedlinePlus related topics: Cataract Surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Outcome Measures:

Reduction of cylinder, Lens axis misalignment as determined by a photographic method. [ Time Frame: 32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lens misalignment as determined by postoperative manifest refraction and vector analysis. [ Time Frame: 32 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	198
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Akreos Toric Intraocular Lens	Device: Akreos Toric IOL Lens implant following cataract surgery
2: Active Comparator Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)	Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) Lens implant following cataract surgery

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.
Subjects who have preoperative corneal astigmatism between the ranges of 1.00D and 1.25D and 2.00D and 2.50D.

Exclusion Criteria:

Subjects who have best-corrected distance visual acuity of 20/200 or worse in the fellow eye.
Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Subjects with corneal pathology potentially affecting topography.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825513

Contacts

Contact: Bev Barna

585-338-6266

Locations

Sweden
Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital	Recruiting
Umea, Sweden, SE-901 85
Contact: Anders Behndig +46-907853731 anders.behndig@ophthal.umu.se
Principal Investigator: Anders Behndig

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Gabriele Brenger

Bausch & Lomb Incorporated

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated ( Keith Edwards )
Study ID Numbers:	566
Study First Received:	January 16, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00825513 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
Refractive Errors
Astigmatism

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on May 07, 2009