Expired Study
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Fort Worth, Texas 76134


Purpose:

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.


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


NCT ID:

NCT00684138


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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