Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

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 intraocular lenses (IOLs) 6 months post cataract surgery.

Official Title
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Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

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 cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40 Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes Preoperative corneal astigmatism of 1.0 D or less Clear intraocular media other than cataract Availability, willingness, and sufficient cognitive awareness to comply with examination procedures Exclusion Criteria: Use of systemic or ocular medications that may affect vision Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) Subjects with diabetes mellitus Uncontrolled systemic or ocular disease History of ocular trauma or prior ocular surgery 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 20/30 or worse Subjects who may be expected to require retinal laser treatment or other surgical intervention Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions) Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses Requiring an intraocular lens <15.0 or >26.0 diopters

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tecnis MF<br> | Device: Tecnis MF<br>* 20 patients in the Tecnis MF group.<br>|
| Active Comparator: ReSTOR<br> | Device: ReSTOR<br>* 20 patients in the ReSTOR group.<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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.