Clinical trial NCT00684138: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Official title: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: cataract
cataract surgery
IOL
intraocular lens
ReSTOR
Replacement of cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
timeFrame: 3 months
Secondary outcomes:
measure: Binocular Distance Corrected Distance Visual Acuity
timeFrame: 3 months post-operative
measure: Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
timeFrame: 3 months post-operative
measure: Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
timeFrame: 3 months post-operative
measure: Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
timeFrame: 3 months post-operative
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Call Center for Locations
state: Texas
Study officials:
References: