ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Condition: Cataract
MeSH terms: Cataract
Intervention: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens; ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Intervention description: Intraocular Lens; Intraocular Lens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 300.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: cataract; cataract surgery; IOL; intraocular lens; ReSTOR; Replacement of cataract

Summary:

      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.
    

Eligibility criteria:

        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