Back to resultsSafety and Effectiveness of the Akreos Toric Intraocular Lens.
Primary Purpose
Cataract, Astigmatism
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Akreos Toric IOL
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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.
Sites / Locations
- Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Akreos Toric
Akreos Advanced
Arm Description
Akreos Toric Intraocular Lens
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Outcomes
Primary Outcome Measures
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
Secondary Outcome Measures
Lens misalignment as determined by postoperative manifest refraction and vector analysis.
Full Information
NCT ID
NCT00825513
First Posted
January 16, 2009
Last Updated
March 19, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00825513
Brief Title
Safety and Effectiveness of the Akreos Toric Intraocular Lens.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Akreos Toric
Arm Type
Experimental
Arm Description
Akreos Toric Intraocular Lens
Arm Title
Akreos Advanced
Arm Type
Active Comparator
Arm Description
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Intervention Type
Device
Intervention Name(s)
Akreos Toric IOL
Intervention Description
Lens implant following cataract surgery
Intervention Type
Device
Intervention Name(s)
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
Intervention Description
Lens implant following cataract surgery
Primary Outcome Measure Information:
Title
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
Time Frame
32 months
Secondary Outcome Measure Information:
Title
Lens misalignment as determined by postoperative manifest refraction and vector analysis.
Time Frame
32 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Brenger
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital
City
Umea
ZIP/Postal Code
SE-901 85
Country
Sweden
12. IPD Sharing Statement
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Safety and Effectiveness of the Akreos Toric Intraocular Lens.
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