This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes.
The study will evaluate the safety and effectiveness of the enVista Beyond (EY) EDF IOL in providing increased depth of focus, comparable distance and improved near and intermediate visual acuity compared to the parent enVista monofocal IOL. This is a prospective, multicenter, randomized, controlled, subject and visual acuity assessor masked, parallel-group study in subjects bilaterally implanted with either EY or enVista MX60E monofocal IOL following cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
304
enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
enVista MX60E monofocal IOL
Site 119
Dothan, Alabama, United States
Site 108
Northridge, California, United States
Site 116
Alexandria, Minnesota, United States
Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
Monocular photopic DCIVA (logMAR) will be measured at 66 cm in the first implanted eye.
Time frame: Day 120 to Day 180 after second eye implantation
Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
Monocular photopic DCIVA (logMAR) will be measured at 66 cm in the first implanted eye.
Time frame: Day 120 to Day 180 after second eye implantation
Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.
Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR in the first implanted eye.
Time frame: Day 120 to Day 180 after second eye implantation
Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.
Monocular Photopic Best-Corrected Distance Visual Acuity (BCDVA) (logMAR) will be measured at 4 meters in the first implanted eye.
Time frame: Day 120 to Day 180 after second eye implantation
Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.
Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better in the first implanted eye. Monocular Photopic Best-Corrected Distance Visual Acuity (BCDVA) (logMAR) will be measured at 4 meters.
Time frame: Day 120 to Day 180 after second eye implantation
Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4.
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Site 107
Bloomington, Minnesota, United States
Site 101
Omaha, Nebraska, United States
Site 109
Las Vegas, Nevada, United States
Site 113
Garden City, New York, United States
Site 118
West Fargo, North Dakota, United States
Site 102
Brecksville, Ohio, United States
Site 105
North Charleston, South Carolina, United States
...and 6 more locations
Monocular photopic DCNVA (logMAR) will be measured at 40 cm in the first implanted eye.
Time frame: Day 120 to Day 180 after second eye implantation