Back to resultsVisual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReSTOR
Tecnis
Acri.LISA
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring ReSTOR
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with cataracts
Exclusion Criteria:
- Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ReSTOR Aspheric +4
Tecnis MF
Acri.LISA
Arm Description
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Outcomes
Primary Outcome Measures
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00721253
Brief Title
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
Official Title
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
ReSTOR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReSTOR Aspheric +4
Arm Type
Active Comparator
Arm Description
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
Arm Title
Tecnis MF
Arm Type
Active Comparator
Arm Description
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
Arm Title
Acri.LISA
Arm Type
Active Comparator
Arm Description
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Intervention Type
Device
Intervention Name(s)
ReSTOR
Intervention Description
Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
Intervention Type
Device
Intervention Name(s)
Tecnis
Intervention Description
Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
Intervention Type
Device
Intervention Name(s)
Acri.LISA
Intervention Description
Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Contrast Sensitivity
Description
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.
Time Frame
6 months
Title
Defocus Curve
Description
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.
Time Frame
6 months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with cataracts
Exclusion Criteria:
Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
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