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

Alcon

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT00684138

C-06-40

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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