Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AcrySof® ReSTOR® Aspheric IOL

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)

Group Type EXPERIMENTAL

AcrySof® ReSTOR® Aspheric IOL

Intervention Type DEVICE

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Interventions

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AcrySof® ReSTOR® Aspheric IOL

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No