Safety and Effectiveness of the Akreos Toric Intraocular Lens.

March 19, 2013 updated by: Bausch & Lomb Incorporated

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden, SE-901 85
        • Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
Time Frame: 32 months
32 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lens misalignment as determined by postoperative manifest refraction and vector analysis.
Time Frame: 32 months
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Gabriele Brenger, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 566

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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