Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens

Conditions
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Cataract, Aphakia

Intervention / Treatment
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* Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Akreos TL intraocular lens<br>Bausch & Lomb Akreos TL intraocular lens | Device: The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL<br>* Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bast Corrected Visual Acuity | best-corrected visual acuity (BCVA) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity |  | 24 months | 
| Manifest Refraction | mean manifest refraction | 24 Months |