Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00684138
First received: May 22, 2008
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataract
 Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.


Secondary Outcome Measures:
  • Binocular Distance Corrected Distance Visual Acuity [ Time Frame: 3 months post-operative ] [ Designated as safety issue: No ]
    Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

  • Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) [ Time Frame: 3 months post-operative ] [ Designated as safety issue: No ]
    Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

  • Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) [ Time Frame: 3 months post-operative ] [ Designated as safety issue: No ]
    Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

  • Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) [ Time Frame: 3 months post-operative ] [ Designated as safety issue: No ]
    Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).


Enrollment: 300
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR Aspheric +3.0D
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
 Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
Intraocular Lens
Active Comparator: ReSTOR Aspheric +4.0D
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
 Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Intraocular Lens

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684138

Locations
United States, Texas
Call Center for Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Tonya Tubbs Jones, Alcon
ClinicalTrials.gov Identifier: NCT00684138     History of Changes
Other Study ID Numbers: C-06-40
Study First Received: May 22, 2008
Results First Received: January 30, 2009
Last Updated: July 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
cataract
cataract surgery
IOL
 intraocular lens
ReSTOR
Replacement of cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013