Clinical Investigation of Expanded Designs of a Multifocal IOL
NCT ID: NCT01714635
Last Updated: 2015-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
445 participants
INTERVENTIONAL
2012-11-30
2014-07-31
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
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tecnis Multifocal Intraocular lens #1
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
Tecnis Multifocal Intraocular Lens #2
A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens
Monofocal Intraocular Lens
Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens
Interventions
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Tecnis Multifocal Intraocular Lens
Monofocal Intraocular Lens
Eligibility Criteria
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Inclusion Criteria
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source
* Potential for postoperative best-corrected visual acuity of 20/25 or better
* Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism
* Clear intraocular media, other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
* Ability to understand and respond to a questionnaire verbally administered in English
Exclusion Criteria
* Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
* Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
* Inability to achieve keratometric stability for contact lens wearers
* Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
* Use of systemic or ocular medications that may affect vision
* Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
* Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
* Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
* Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction
18 Years
ALL
Yes
Sponsors
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Abbott Medical Optics
INDUSTRY
Responsible Party
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Principal Investigators
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Kendra Hileman, PhD
Role: STUDY_DIRECTOR
Abbott Medical Optics
Locations
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Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
Tucson, Arizona, United States
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States
Empire Eye & Laser Center
Bakersfield, California, United States
Assil Eye Institute
Beverly Hills, California, United States
Cape Coral Eye Center (Argus Research Center)
Cape Coral, Florida, United States
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Wallace Eye Surgery
Alexandria, Louisiana, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
The Eye Center of Central PA
Allenwood, Pennsylvania, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Bucci Cataract & Laser Vision
Wilkes-Barre, Pennsylvania, United States
Loden Vision Center
Goodlettsville, Tennessee, United States
Whitsett Vision Group
Houston, Texas, United States
Lone Star Eye Care
Sugar Land, Texas, United States
Clarus Eye Centre
Lacey, Washington, United States
The Midline Eye Institute
Solihull, , United Kingdom
Countries
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Other Identifiers
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DIOL-106-ZMLA
Identifier Type: -
Identifier Source: org_study_id
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