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

NCT ID: NCT00684138

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-06-30

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® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ReSTOR Aspheric +3.0D

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Intraocular Lens

ReSTOR Aspheric +4.0D

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Intraocular Lens

Interventions

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

Intraocular Lens

Intervention Type: DEVICE

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

Intraocular Lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Alcon

Locations

Call Center for Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

C-06-40

Identifier Type: -

Identifier Source: org_study_id