Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Study Overview
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Brief Summary
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This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Official Title
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Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® ReSTOR® Aspheric IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years or older; need spherical correction between 10-30 Diopters (D); corneal astigmatism less than 0.75D as measured by keratometry; willing to sign an Informed Consent Form and complete all visits; pupil dilation greater than 6mm; expected Visual Acuity (measured in logMAR)=0.3 or better Exclusion Criteria: Women of childbearing potential; irregular corneal astigmatism; keratopathy/keratectasia; cornea inflammation or edema; cornea reshaping surgery; corneal dystrophy;corneal transplant; amblyopia; glaucoma; Retinal Pigment Epitheliopathy (RPE)/Macular changes; proliferative diabetic retinopathy

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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcrySof® ReSTOR® Aspheric IOL<br>AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) | Device: AcrySof® ReSTOR® Aspheric IOL<br>* AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. | pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectacle Independence | Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported. | pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery | 

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