ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL) (NCT00684138) | Clinical Trial Compass
CompletedPhase 4
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
United States300 participantsStarted 2007-06
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Pre…
What they're measuring
1
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)