Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
NCT ID: NCT03280108
Last Updated: 2019-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2017-11-01
2018-09-27
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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Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
Monofocal IOL
AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
AcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision
Interventions
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AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
AcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
* Clear intraocular media other than cataract in both eyes.
* Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.
Exclusion Criteria
* Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
* Glaucoma (uncontrolled or controlled with medication)
* Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
* Pregnant or lactating
* Expected to require a second surgical intervention or retinal laser treatment.
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Alcon Research
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Alcon Investigative Site
Fresno, California, United States
Alcon Investigative Site
Mt. Dora, Florida, United States
Alcon Investigative Site
Panama City, Florida, United States
Alcon Investigative Site
Poughkeepsie, New York, United States
Alcon Investigative Site
Mt. Pleasant, South Carolina, United States
Alcon Investigative Site
Sioux Falls, South Dakota, United States
Alcon Investigative Site
Nashville, Tennessee, United States
Alcon Investigative Site
Houston, Texas, United States
Alcon Investigative Site
Hurst, Texas, United States
Alcon Investigative Site
Nacogdoches, Texas, United States
Alcon Investigative Site
Salt Lake City, Utah, United States
Alcon Investigative Site
Norfolk, Virginia, 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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ILH297-C001
Identifier Type: -
Identifier Source: org_study_id
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