Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Tecnis MF IOL
|
Device: Tecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
|
Active Comparator: Crystalens AO IOL
|
Device: Crystalens AO IOL
20 patients enrolled with the Crystalens AO
|
Outcome Measures
Primary Outcome Measures
- Refraction [1 year]
- Distance Visual Acuities [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or greater
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Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
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Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
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Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
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Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
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Preoperative corneal astigmatism of 1.0 D or less
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Clear intraocular media other than cataract
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Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
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Use of systemic or ocular medications that may affect vision
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Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
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Subjects with diabetes mellitus
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Uncontrolled systemic or ocular disease
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History of ocular trauma or prior ocular surgery
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Amblyopia or strabismus
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Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
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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
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Subjects who may be expected to require retinal laser treatment or other surgical intervention
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Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
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Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
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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
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Requiring an intraocular lens < 15.0 or > 26.0 diopters
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Farrell Tyson | Cape Coral | Florida | United States |
Sponsors and Collaborators
- Innovative Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tecnis MF/Crystalens