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
  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:


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 April 22, 2014