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OpenTrials
Completed

NCT Number: NCT00684138

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Call Center for Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Intraocular Lens

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

Device

Intraocular Lens

Primary outcomes

  1. Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)

    Time frame: 3 months

    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 outcomes

  1. Binocular Distance Corrected Distance Visual Acuity

    Time frame: 3 months post-operative

    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).

  2. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)

    Time frame: 3 months post-operative

    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).

  3. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)

    Time frame: 3 months post-operative

    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).

  4. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)

    Time frame: 3 months post-operative

    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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 26, 2008
Registry last updated
Jul 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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