The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, United States
Moyes Eye Center
Kansas City, Missouri, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual Acuity (VA) was assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA was measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.
Time frame: Month 2 postoperative
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Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Vision for Life
Nashville, Tennessee, United States
Houston Eye Associates
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States