Safety and Effectiveness of the Akreos Toric Intraocular Lens.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00825513
First received: January 16, 2009
Last updated: March 19, 2013
Last verified: March 2013

January 16, 2009
March 19, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00825513
566
No
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