Status:
TERMINATED
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the...
Eligibility Criteria
Inclusion
- Subjects must have a clinically documented diagnosis of age-related cataract.
- Subjects must have clear intraocular media other than cataract.
- Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
Exclusion
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnosis of degenerative visual disorder.
- Subjects who have any inflammation or edema (swelling) of the cornea.
- Subjects with immunodeficiency disorders.
- Subjects who have had previous intraocular surgery in the study eye.
- Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
- Subjects with chronic use of systemic steroids or immunosuppressive medications.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00804726
Start Date
November 1 2008
End Date
July 1 2010
Last Update
January 17 2014
Active Locations (1)
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1
Augenzentrum Maus Wolfsstr 16
Cologne, Germany, 50667