Status:
COMPLETED
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Aphakia
Eligibility:
All Genders
50-79 years
Phase:
PHASE4
Brief Summary
This study is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
Eligibility Criteria
Inclusion
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
- Subjects must require a lens power from 15 to 30 diopters.
- Subjects must have a visual potential of 20/40 or better in the study eye.
Exclusion
- Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- Subjects with any inflammation or edema (swelling) of the cornea.
- Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
- Subjects with previous retinal detachment.
- Subjects with diabetic retinopathy (proliferative or non-proliferative).
- Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
- Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
- Subjects who have already received an Akreos TL IOL in the fellow eye.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00838045
Start Date
September 1 2006
End Date
September 1 2008
Last Update
December 9 2011
Active Locations (1)
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1
Klinikum der J.W. Goethe-Universität
Frankfurt, Germany, 60590