Cataract Clinical Trial
Official title:
A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | September 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 79 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum der J.W. Goethe-Universität | Frankfurt |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bast Corrected Visual Acuity | best-corrected visual acuity (BCVA) | 24 months | No |
Secondary | Uncorrected Visual Acuity | 24 months | No | |
Secondary | Manifest Refraction | mean manifest refraction | 24 Months | No |
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