Safety and Effectiveness of the Akreos Toric Intraocular Lens.
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00825513
Collaborator
(none)
198
1
2
43
4.6
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
198 participants
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
Study Start Date
:
Feb 1, 2009
Actual Primary Completion Date
:
Mar 1, 2012
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Reduction of cylinder, Lens axis misalignment as determined by a photographic method. [32 months]
Secondary Outcome Measures
- Lens misalignment as determined by postoperative manifest refraction and vector analysis. [32 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00825513
Other Study ID Numbers:
- 566
First Posted:
Jan 21, 2009
Last Update Posted:
Mar 25, 2013
Last Verified:
Mar 1, 2013