nctId: NCT06333015 id: 924 briefTitle: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-27 date: 2024-04-29 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: 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. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: 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. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: enVista EY Beyond IOL name: TECNIS 1-Piece monofocal IOL measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4. measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 108 city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Site 107 city: Bloomington state: Minnesota zip: 55420 country: United States lat: 44.8408 lon: -93.29828 facility: Site 101 city: Omaha state: Nebraska zip: 68137 country: United States lat: 41.25626 lon: -95.94043 facility: Site 109 city: Las Vegas state: Nevada zip: 89145 country: United States lat: 36.17497 lon: -115.13722 facility: Site 102 city: Brecksville state: Ohio zip: 44141 country: United States lat: 41.31978 lon: -81.62679 facility: Site 105 city: North Charleston state: South Carolina zip: 29406 country: United States lat: 32.85462 lon: -79.97481 facility: Site 106 city: Sioux Falls state: South Dakota zip: 57108 country: United States lat: 43.54997 lon: -96.70033 facility: Site 103 city: Dallas state: Texas zip: 75243 country: United States lat: 32.78306 lon: -96.80667 facility: Site 111 city: Mount Pleasant state: Wisconsin zip: 53405 country: United States lat: 42.69743 lon: -87.85577 facility: Site 110 city: Calgary state: Alberta zip: T2N 1N4 country: Canada lat: 51.05011 lon: -114.08529 facility: Site 104 city: Montréal state: Quebec zip: H1V 1G5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False