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
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: ReSTOR Device: Tecnis Device: Acri.LISA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: ReSTOR Aspheric +4
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
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
Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
Active Comparator: Acri.LISA
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
- 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.
- 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.
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
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|