Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

Study Overview
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Brief Summary
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The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).

Official Title
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Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof ReSTOR Aspheric IOL model SN6AD1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits. Exclusion Criteria: Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under Precautions for subject groups that should be excluded from this study. All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3 Multifocal Lens<br>Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) | Device: AcrySof ReSTOR Aspheric IOL model SN6AD1<br>* Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Visual Acuity at Distance, Near and Intermediate | Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, Bilateral Cataract, ReSTOR, Aspheric