The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
501
enVista MX60E monofocal IOL
enVista MX60EF (trifocal) multifocal IOL (MIOL)
Bausch Site 108
Fayetteville, Arkansas, United States
Bausch Site 113
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Serious Adverse Events
All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
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Garden Grove, California, United States
Bausch Site 120
Northridge, California, United States
Bausch Site 115
Redding, California, United States
Bausch Site 103
Torrance, California, United States
Bausch Site 107
Mt. Dora, Florida, United States
Bausch Site 117
Lake Villa, Illinois, United States
Bausch Site 101
Bloomington, Minnesota, United States
Bausch Site 119
Birmingham, Mississippi, United States
Bausch Site 102
St Louis, Missouri, United States
...and 13 more locations
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes
Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)
Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
First-eye BCDVA Evaluated at Postoperative Visit 5
First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCNVA Evaluated at Postoperative Visit 5
First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
First-eye DCIVA Evaluated at Postoperative Visit 5
First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)
Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline