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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00721253
First received: July 21, 2008
Last updated: March 4, 2010
Last verified: March 2010

July 21, 2008
March 4, 2010
July 2007
October 2008   (final data collection date for primary outcome measure)
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Visual Acuity at distance, near and intermediate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00721253 on ClinicalTrials.gov Archive Site
  • Contrast Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Low Contrast Acuity, Contrast Sensitivity, Defocus Curve [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cataract
  • Device: ReSTOR
    Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
  • Device: Tecnis
    Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
  • Device: Acri.LISA
    Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
  • Active Comparator: ReSTOR Aspheric +4
    ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
    Intervention: Device: ReSTOR
  • Active Comparator: Tecnis MF
    Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
    Intervention: Device: Tecnis
  • Active Comparator: Acri.LISA
    Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
    Intervention: Device: Acri.LISA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with cataracts

Exclusion Criteria:

  • Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721253
M07-002
No
Rick Potvin, Alcon
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP