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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
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

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 ]

Enrollment: 198
Study Start Date: February 2009
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Akreos Toric
Akreos Toric Intraocular Lens
 Device: Akreos Toric IOL
Lens implant following cataract surgery
Active Comparator: Akreos Advanced
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
 Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Lens implant following cataract surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • 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

Locations
Sweden
Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital
Umea, Sweden, SE-901 85
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Gabriele Brenger Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00825513     History of Changes
Other Study ID Numbers: 566
Study First Received: January 16, 2009
Last Updated: March 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 23, 2013