Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

Study Overview
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Brief Summary
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The purpose of the study is: to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT) to assess patient satisfaction before and after implant

Conditions
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Cataract

Intervention / Treatment
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* Device: Acrysof Natural ReSTOR SN60D3
* Device: Acrysof Natural Monofocal SN60AT


Participation Criteria
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Eligibility Criteria
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Inclusion: Written informed consent Age: ≥ 50 years ≤ 75 years Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs) Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings Potential post operative Visual Acuity (VA) ≥ 20/40 Second eye surgery to take place no longer than 45 days after the first implant Exclusion: Irregular optical aberrations; Pupil diameter in scotopic conditions more than 6 mm Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD)) Other exclusions as from ReSTOR Directions for Use (DFU)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SN60D3<br>AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3 | Device: Acrysof Natural ReSTOR SN60D3<br>* Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.<br>|
| Active Comparator: SN60AT<br>AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT | Device: Acrysof Natural Monofocal SN60AT<br>* Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Best Corrected Visual Acuity (BCVA) - Binocular | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation | 
| Near Uncorrected Visual Acuity (UCVA) Binocular | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation | 
| Near Best Corrected Visual Acuity Left Eye (BCVA LE) | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation | 
| Near Uncorrected Visual Acuity Left Eye (UCVA LE) | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation | 
| Near Best Corrected Visual Acuity Right Eye (BCVA RE) | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation | 
| Near Uncorrected Visual Acuity Right Eye (UCVA RE) | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after second eye implantation |