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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721253
First Posted: July 24, 2008
Last Update Posted: March 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
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 Intervention Phase
Cataract Device: ReSTOR Device: Tecnis Device: Acri.LISA Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Enrollment: 42
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Rick Potvin, Alcon
ClinicalTrials.gov Identifier: NCT00721253     History of Changes
Other Study ID Numbers: M07-002
First Submitted: July 21, 2008
First Posted: July 24, 2008
Results First Submitted: September 18, 2009
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:
Cataract
Lens Diseases
Eye Diseases