Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
NCT ID: NCT01061281
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2010-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tecnis MF IOL
Tecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
Crystalens AO IOL
Crystalens AO IOL
20 patients enrolled with the Crystalens AO
Interventions
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Tecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
Crystalens AO IOL
20 patients enrolled with the Crystalens AO
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Innovative Medical
INDUSTRY
Responsible Party
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Cape Coral Eye Center
Locations
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Farrell Tyson
Cape Coral, Florida, United States
Countries
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Other Identifiers
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Tecnis MF/Crystalens
Identifier Type: -
Identifier Source: org_study_id
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