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

July 6, 2010 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Call Center for Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months post-operative
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 months post-operative
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).
3 months post-operative
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).
3 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-06-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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