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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enVista Beyond EY IOL | Experimental | Subjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY |
|
| enVista MX60E monofocal IOL | Active Comparator | Subjects implanted with enVista MX60E monofocal IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enVista Beyond EY (EDF) IOL | Device | enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Day 120 to Day 180 after second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4. | Monocular photopic DCNVA (logMAR) will be measured at 40 cm in the first implanted eye. | Day 120 to Day 180 after second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosangela Sonner | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 119 | Dothan | Alabama | 36301 | United States | ||
| Site 108 |
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Approximately 299 subjects will be randomized in the study. In the first phase 224 subjects will be randomized at a 1:1 ratio to either the test or control IOL, and in the second phase 75 subjects will be randomized at a 2:1 ratio to either the test or control IOL.
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Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject.
| enVista MX60E monofocal IOL | Device | enVista MX60E monofocal IOL |
|
| Northridge |
| California |
| 91325 |
| United States |
| Site 116 | Alexandria | Minnesota | 56308 | United States |
| Site 107 | Bloomington | Minnesota | 55420 | United States |
| Site 101 | Omaha | Nebraska | 68137 | United States |
| Site 109 | Las Vegas | Nevada | 89145 | United States |
| Site 113 | Garden City | New York | 11530 | United States |
| Site 118 | West Fargo | North Dakota | 58078 | United States |
| Site 102 | Brecksville | Ohio | 44141 | United States |
| Site 105 | North Charleston | South Carolina | 29406 | United States |
| Site 106 | Sioux Falls | South Dakota | 57108 | United States |
| Site 103 | Dallas | Texas | 75243 | United States |
| Site 117 | San Antonio | Texas | 78209 | United States |
| Site 112 | San Antonio | Texas | 78229 | United States |
| Site 115 | Sugar Land | Texas | 77478 | United States |
| Site 111 | Mount Pleasant | Wisconsin | 53405 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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