Phase 4
N=280
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00684138 ↗Enrolled (actual)
280
Serious AEs
2.2%
Results posted
Mar 2010
Primary outcome: Primary: Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) — 0.07; 0.09 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens (Device); ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) |
0.07; 0.09 | — |
| SECONDARY Binocular Distance Corrected Distance Visual Acuity |
-0.05; -0.05 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) |
0.06; 0.24 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) |
0.12; 0.32 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) |
0.18; 0.34 | — |
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
Data sourced from ClinicalTrials.gov (NCT00684138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.