Status:
COMPLETED
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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® ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00684138
Start Date
June 1 2007
End Date
June 1 2008
Last Update
July 13 2010
Active Locations (1)
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1
Call Center for Locations
Fort Worth, Texas, United States, 76134