AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Study Overview
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Brief Summary
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The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

Detailed Description
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The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

Official Title
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AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: Tecnis MF
* Device: ReSTOR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or greater Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation Clear intraocular media other than cataract Normal OCT of the macula No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam Availability, willingness, and sufficient cognitive awareness to comply with examination procedures Exclusion Criteria: Use of systemic or ocular medications that may affect vision Uncontrolled systemic or ocular disease History of ocular trauma History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction) Amblyopia or strabismus Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy) Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Other: Tecnis MF<br> | Device: Tecnis MF<br>* 30 subjects will be implanted with the Tecnis MF<br>|
| Other: ReSTOR<br> | Device: ReSTOR<br>* 30 subjects will be implanted with ReSTOR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction |  | 1 year | 
| Distance Visual Acuities |  | 1 year | 
| Near Visual Acuities |  | 1 year | 
| Intermediate Acuities |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery