Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL
NCT ID: NCT01275118
Last Updated: 2014-02-28
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
26 participants
INTERVENTIONAL
2010-12-31
2011-09-30
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
Interventions
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Tecnis Multifocal IOL
Presbyopia correcting IOL
crystalens Accommodating IOL
Presbyopia correcting IOL
Eligibility Criteria
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Inclusion Criteria
* Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
* Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
* Use of systemic or ocular medications that may affect visual outcomes
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma
* History of ocular surgery other than that required for inclusion in this study
* 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 worse than 20/30
* 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 or abnormally shaped pupils)
18 Years
ALL
No
Sponsors
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Abbott Medical Optics
INDUSTRY
Mark Packer, MD, FACS
OTHER
Responsible Party
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Mark Packer, MD, FACS
Sponsor-Investigator
Principal Investigators
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Mark Packer, MD, FACS, CPI
Role: PRINCIPAL_INVESTIGATOR
Drs. Fine, Hoffman and Packer, LLC
Locations
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Drs. Fine, Hoffman and Packer, LLC
Eugene, Oregon, United States
Countries
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Other Identifiers
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TMF-09-002 Rev.5
Identifier Type: -
Identifier Source: org_study_id
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