A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses

Study Overview
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Brief Summary
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To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).

Official Title
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A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)

Conditions
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Cataract

Intervention / Treatment
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* Device: ReSTOR +3
* Device: LENTIS MPlus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are willing and able to understand and sign an informed consent <= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure regular astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements. are willing and able to attend postoperative examinations per protocol schedule are more than 21 years of age, of either gender and any race: require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure be willing to have second eye surgery within one month of first eye surgery are in good ocular health, with the exception of cataracts are free of disease(s)/condition(s) listed in the Precautions section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts are able to read and understand one of the following languages: Dutch or Spanish Exclusion Criteria: Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.) Previous corneal surgery and/or reshaping Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy) History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.) History of retinal detachment Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness). suturing of incision required at time of surgery

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3<br>Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 | Device: ReSTOR +3<br>* Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.<br>|
| Active Comparator: LENTIS MPlus<br>Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model | Device: LENTIS MPlus<br>* Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unilateral Uncorrected Near Visual Acuity |  | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, Presbyopia Correcting IOL