ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Study Overview
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Brief Summary
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Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

Official Title
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ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Conditions
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Cataract

Intervention / Treatment
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* Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
* Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens


Participation Criteria
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Eligibility Criteria
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Inclusion: Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts Calculated lens power is within the available range Willing and able to complete all required postoperative visits Planned cataract removal by phacoemulsification and/or liquifacture Potential postoperative visual acuity of 0.2 logMAR or better in study eyes Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes Clear intraocular media other than cataract in study eyes Able to comprehend and sign a statement of informed consent Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on Medium setting must be worse than 0.2 logMAR Exclusion: Significant irregular corneal aberration as demonstrated by corneal topography Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR Subjects who may reasonably be expected to require laser treatments at any time Previous corneal refractive surgery Amblyopia Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) Diabetic retinopathy Extremely shallow anterior chamber, not due to swollen cataract Microphthalmos Previous retinal detachment Previous corneal transplant Recurrent severe anterior or posterior segment inflammation of unknown etiology Rubella or traumatic cataract Iris neovascularization Glaucoma (uncontrolled or controlled with medication) Aniridia Optic nerve atrophy Pregnancy Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®) Any subject currently participating in another investigational drug or device study that may confound the results of this investigation

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR Aspheric +3.0D<br>ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens | Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens<br>* Intraocular Lens<br>|
| Active Comparator: ReSTOR Aspheric +4.0D<br>ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens | Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens<br>* Intraocular Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance Corrected Distance Visual Acuity | Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative | 
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative | 
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative | 
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, cataract, cataract surgery, intraocular lens, ReSTOR, Replacement of cataract