Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating 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 Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.

Official Title
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Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

Conditions
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Aphakia

Intervention / Treatment
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* Device: Tecnis MF IOL
* Device: Crystalens AO IOL


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 20/25 or better in each eye after cataract removal and IOL implantation Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen Naturally dilated pupil size (in dim light) > 4.0 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 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tecnis MF IOL<br> | Device: Tecnis MF IOL<br>* 20 patients enrolled with the Tecnis MF IOL.<br>|
| Active Comparator: Crystalens AO IOL<br> | Device: Crystalens AO IOL<br>* 20 patients enrolled with the Crystalens AO<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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Aphakia following refractive lensectomy to treat presbyopia