Study Results
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View full resultsBasic Information
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COMPLETED
NA
365 participants
INTERVENTIONAL
2015-10-21
2019-05-23
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
NONE
Study Groups
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non-toric intraocular lens
non-toric approved intraocular lens
non-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00
toric intraocular lens
approved toric intraocular lens
toric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400
Interventions
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non-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00
toric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400
Eligibility Criteria
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Inclusion Criteria
* Bilateral cataracts
* Preoperative keratometric cylinder in both eyes
* Most appropriate toric IOL model choice (ZCT300 or ZCT400)
* Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
* Clear intraocular media other than cataract in each eye
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
* Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
* Signed informed consent and HIPAA authorization
Exclusion Criteria
* Any corneal pathology/abnormality other than regular corneal astigmatism
* Previous corneal surgery
* Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
* Any pupil abnormalities
* 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
* Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
* Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
* Planned monovision correction
* 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
22 Years
ALL
No
Sponsors
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Abbott Medical Optics
INDUSTRY
Responsible Party
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Principal Investigators
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Devi Priya Janakiraman, OD, FAAO
Role: STUDY_DIRECTOR
Johnson & Johnson Surgical Vision
Locations
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Eye Center South
Dothan, Alabama, United States
Arizona Eye Cente
Chandler, Arizona, United States
Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
Tucson, Arizona, United States
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States
Empire Eye & Laser Center
Bakersfield, California, United States
Atlantis Eye Care
Huntington Beach, California, United States
Scripps Clinic Medical Group
La Jolla, California, United States
Southern California Eye Physicians & Associates
Long Beach, California, United States
Feinerman Vision Center
Newport Beach, California, United States
Coastal Vision
Orange, California, United States
California Eye Medical Specialists
Pasadena, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
Katzen Eye Care & Laser Center
Boynton Beach, Florida, United States
The Eye Associates
Bradenton, Florida, United States
Cape Coral Eye Center
Cape Coral, Florida, United States
Levenson Eye Associates, Inc.
Jacksonville, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, United States
Senior Health Services
Louisville, Kentucky, United States
Chesapeake Eye Care and Laser Center
Annapolis, Maryland, United States
Solomon Eye Associates
Bowie, Maryland, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
Oakland Ophthalmic Surgery, P.C.
Birmingham, Michigan, United States
TLC Eye Care and Laser Centers
Chelsea, Michigan, United States
Mercy Clinic Eye Specialist
Springfield, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Ophthalmology Consultants
St Louis, Missouri, United States
Kindermann Eye Associates
Cherry Hill, New Jersey, United States
Matossian Eye Associates
Pennington, New Jersey, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Pamel Vision & Laser Group
New York, New York, United States
Fine, Hoffman & Sims
Eugene, Oregon, United States
The Eye Center of Central PA
Allenwood, Pennsylvania, United States
Ludwick Eye Center
Chambersburg, Pennsylvania, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Loden Vision Centers
Goodlettsville, Tennessee, United States
Houston Eye Associates
Houston, Texas, United States
Whitsett Vision Group
Houston, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
San Antonio Eye Specialists
San Antonio, Texas, United States
Clarus Eye Centre
Lacey, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TIOL-202-TPAS
Identifier Type: -
Identifier Source: org_study_id
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