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

Study Overview
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Brief Summary
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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

Official Title
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Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: ReSTOR
* Device: Tecnis
* Device: Acri.LISA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cataracts Exclusion Criteria: Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReSTOR Aspheric +4<br>ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 | Device: ReSTOR<br>* Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)<br>|
| Active Comparator: Tecnis MF<br>Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900 | Device: Tecnis<br>* Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)<br>|
| Active Comparator: Acri.LISA<br>Meditec Acri.LISA Intraocular Lens (IOL) Model 366D | Device: Acri.LISA<br>* Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 6 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ReSTOR