Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.

Study Overview
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Brief Summary
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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 demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.

Official Title
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A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.

Conditions
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Cataract

Intervention / Treatment
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* Device: Akreos MI Five-O


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. 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Akreos MI Five-O<br>Accommodating intraocular lens | Device: Akreos MI Five-O<br>* Small incision cataract surgery with phacoemulsification cataract extraction and Akreos MI Five-O IOL surgical implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction | 5 visits up to 420 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Best corrected near Visual acuity Intermediate visual acuity with distance best correction Subjective near point of accommodation (push down test) | 5 visits up to 420 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract extraction, Phacoemulsification