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
  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 Blind (Subject)
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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rick Potvin, Alcon
ClinicalTrials.gov Identifier: NCT00721253     History of Changes
Other Study ID Numbers: M07-002
Study First Received: July 21, 2008
Results First Received: September 18, 2009
Last Updated: March 4, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by Alcon Research:
ReSTOR

ClinicalTrials.gov processed this record on October 19, 2014