Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

Detailed Description
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The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

Official Title
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Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

Conditions
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Cataract

Intervention / Treatment
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* Device: Aspheric Acrysof ReSTOR intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have an age-related cataract in both eyes. 40 years of age or older. Patient must desire cataract extraction. Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries. Willing and able to comply with scheduled visits and other study procedures Exclusion Criteria: Preoperative ocular pathology potentially affecting visual acuity. Keratometric astigmatism exceeding 1.50 diopters. Planned postoperative refraction for mono-vision. Uncontrolled diabetes. Use of any systemic or topical drug known to interfere with visual performance. Contact lens use during the active treatment portion of the trial. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye. Other ocular surgery at the time of the cataract extraction.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspheric Acrysof ResTOR Lens<br>Implantation of Aspheric Acrysof ResTOR | Device: Aspheric Acrysof ReSTOR intraocular lens<br>* Bilateral implantation of Aspheric Acrysof ReSTOR<br>* Other names: Acrysof ReSTOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance). |  | Preoperatively, 1, 3 and 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire. |  | preoperatively, 1, 3, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, cataract extraction, intraocular lens, age related