Status:
COMPLETED
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal I...
Detailed Description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of the...
Eligibility Criteria
Inclusion
- Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
- 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
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2018
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03280108
Start Date
November 1 2017
End Date
September 27 2018
Last Update
October 10 2019
Active Locations (12)
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1
Alcon Investigative Site
Fresno, California, United States, 93720
2
Alcon Investigative Site
Mt. Dora, Florida, United States, 32757
3
Alcon Investigative Site
Panama City, Florida, United States, 32405
4
Alcon Investigative Site
Poughkeepsie, New York, United States, 12603