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Safety and Effectiveness of the Akreos Toric Intraocular Lens.

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: January 16, 2009
Last updated: March 19, 2013
Last verified: March 2013
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Condition Intervention Phase
Device: Akreos Toric IOL
Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:

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 ]

Secondary Outcome Measures:
  • Lens misalignment as determined by postoperative manifest refraction and vector analysis. [ Time Frame: 32 months ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00825513

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

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00825513     History of Changes
Other Study ID Numbers: 566
Study First Received: January 16, 2009
Last Updated: March 19, 2013

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Refractive Errors processed this record on May 24, 2017