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Safety and Effectiveness of the Akreos Toric Intraocular Lens.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825513
First Posted: January 21, 2009
Last Update Posted: March 25, 2013
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Single (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00825513     History of Changes
Other Study ID Numbers: 566
First Submitted: January 16, 2009
First Posted: January 21, 2009
Last Update Posted: March 25, 2013
Last Verified: March 2013

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