protocolSection identificationModule nctId: NCT06333015, orgStudyIdInfo id: 924, briefTitle: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: enVista EY Beyond IOL, interventions name: TECNIS 1-Piece monofocal IOL, outcomesModule primaryOutcomes measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4., secondaryOutcomes measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4., eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 108, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Site 107, city: Bloomington, state: Minnesota, zip: 55420, country: United States, geoPoint lat: 44.8408, lon: -93.29828, locations facility: Site 101, city: Omaha, state: Nebraska, zip: 68137, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Site 109, city: Las Vegas, state: Nevada, zip: 89145, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Site 102, city: Brecksville, state: Ohio, zip: 44141, country: United States, geoPoint lat: 41.31978, lon: -81.62679, locations facility: Site 105, city: North Charleston, state: South Carolina, zip: 29406, country: United States, geoPoint lat: 32.85462, lon: -79.97481, locations facility: Site 106, city: Sioux Falls, state: South Dakota, zip: 57108, country: United States, geoPoint lat: 43.54997, lon: -96.70033, locations facility: Site 103, city: Dallas, state: Texas, zip: 75243, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Site 111, city: Mount Pleasant, state: Wisconsin, zip: 53405, country: United States, geoPoint lat: 42.69743, lon: -87.85577, locations facility: Site 110, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Site 104, city: Montréal, state: Quebec, zip: H1V 1G5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False