AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
NCT ID: NCT01278420
Last Updated: 2012-06-14
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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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2010-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tecnis MF
Tecnis MF
30 subjects will be implanted with the Tecnis MF
ReSTOR
ReSTOR
30 subjects will be implanted with ReSTOR
Interventions
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Tecnis MF
30 subjects will be implanted with the Tecnis MF
ReSTOR
30 subjects will be implanted with ReSTOR
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Innovative Medical
INDUSTRY
Responsible Party
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The Center for Excellence in Eye Care
Principal Investigators
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William Trattler, MD
Role: PRINCIPAL_INVESTIGATOR
The Center for Excellence in Eye Care
Mitch Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Jackson Eye
Larry Katzen, MD
Role: PRINCIPAL_INVESTIGATOR
Katzen Eye Care & Laser Center
Kevin Waltz, MD
Role: PRINCIPAL_INVESTIGATOR
Eye Surgeons of Indiana
Shamik Bafna, MD
Role: PRINCIPAL_INVESTIGATOR
Clevland Eye Clinic
Locations
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Sansum- Santa Barbara medical foundation Clinic
Santa Barbara, California, United States
Katzen Eye Care & Laser Center
Boynton Beach, Florida, United States
The Center for Excellence in Eye Care
Miami, Florida, United States
Jackson Eye, SC
Lake Villa, Illinois, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Cleveland Eye Clinic
Breckville, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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TMF vs Restor MF 3D
Identifier Type: -
Identifier Source: org_study_id
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