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Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

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ClinicalTrials.gov Identifier: NCT00721253
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Alcon Research

Study Description
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Brief Summary:
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Condition or disease Intervention/treatment Phase
Cataract Device: ReSTOR Device: Tecnis Device: Acri.LISA Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
Study Start Date : July 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ReSTOR Aspheric +4
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
 Device: ReSTOR
Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
Active Comparator: Tecnis MF
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
 Device: Tecnis
Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
Active Comparator: Acri.LISA
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
 Device: Acri.LISA
Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)


Outcome Measures
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Primary Outcome Measures :
  1. Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate [ Time Frame: 6 months ]
    Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.


Secondary Outcome Measures :
  1. Contrast Sensitivity [ Time Frame: 6 months ]
    Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.

  2. Defocus Curve [ Time Frame: 6 months post-operative ]
    Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with cataracts

Exclusion Criteria:

  • Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721253


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Rick Potvin, Alcon
ClinicalTrials.gov Identifier: NCT00721253    
Other Study ID Numbers: M07-002
First Posted: July 24, 2008    Key Record Dates
Results First Posted: March 16, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Alcon Research:
ReSTOR
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases