Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Study Details
Study Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Akreos TL intraocular lens Bausch & Lomb Akreos TL intraocular lens |
Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
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Outcome Measures
Primary Outcome Measures
- Bast Corrected Visual Acuity [24 months]
best-corrected visual acuity (BCVA)
Secondary Outcome Measures
- Uncorrected Visual Acuity [24 months]
- Manifest Refraction [24 Months]
mean manifest refraction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
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Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
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Subjects must require a lens power from 15 to 30 diopters.
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Subjects must have a visual potential of 20/40 or better in the study eye.
Exclusion Criteria:
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Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
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Subjects with any inflammation or edema (swelling) of the cornea.
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Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
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Subjects with previous retinal detachment.
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Subjects with diabetic retinopathy (proliferative or non-proliferative).
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Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
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Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
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Subjects who have already received an Akreos TL IOL in the fellow eye.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Klinikum der J.W. Goethe-Universität | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Thomas Kohnen, Klinikum der J.W. Goethe-Universität
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 451