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Safety and Effectiveness of the Akreos Toric Intraocular Lens.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00825513
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

January 16, 2009
January 21, 2009
March 25, 2013
February 2009
March 2012   (Final data collection date for primary outcome measure)
Reduction of cylinder, Lens axis misalignment as determined by a photographic method. [ Time Frame: 32 months ]
Same as current
Complete list of historical versions of study NCT00825513 on ClinicalTrials.gov Archive Site
Lens misalignment as determined by postoperative manifest refraction and vector analysis. [ Time Frame: 32 months ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of the Akreos Toric Intraocular Lens.
Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Cataract
  • Astigmatism
  • Device: Akreos Toric IOL
    Lens implant following cataract surgery
  • Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
    Lens implant following cataract surgery
  • Experimental: Akreos Toric
    Akreos Toric Intraocular Lens
    Intervention: Device: Akreos Toric IOL
  • Active Comparator: Akreos Advanced
    Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
    Intervention: Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
Same as current
September 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00825513
566
No
Not Provided
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Gabriele Brenger Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP