Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT04098367
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. CDMA Project Lead, Surgical', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months.', 'description': 'An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'All subjects prior to with attempted implantation with any IOL (successful or aborted implant)', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 0, 'seriousNumAtRisk': 193, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VIVITY First Eye', 'description': 'All eyes that had contact with the VIVITY IOL (successful or aborted implant)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 7, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'VIVITY Second Eye', 'description': 'All eyes that had contact with the VIVITY IOL (successful or aborted implant)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 7, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'VIVITY Systemic', 'description': 'All subjects that had contact with the VIVITY IOL (successful or aborted implant)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SYMFONY First Eye', 'description': 'All eyes that had contact with the SYMFONY IOL (successful or aborted implant)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 12, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'SYMFONY Second Eye', 'description': 'All eyes that had contact with the SYMFONY IOL (successful or aborted implant)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 10, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'SYMFONY Systemic', 'description': 'All subjects that had contact with the SYMFONY IOL (successful or aborted implant)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'AT LARA First Eye', 'description': 'All eyes that had contact with the AT LARA IOL (successful or aborted implant)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 17, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'AT LARA Second Eye', 'description': 'All eyes that had contact with the AT LARA IOL (successful or aborted implant)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 16, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'AT LARA Systemic', 'description': 'All subjects that had contact with the AT LARA IOL (successful or aborted implant)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Halo vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Posterior capsule rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Paracentesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lens extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Parathyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Retinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery'}, {'id': 'OG001', 'title': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery'}, {'id': 'OG002', 'title': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '30.6', 'ciLowerLimit': '13.34', 'ciUpperLimit': '46.79', 'estimateComment': 'VIVITY minus SYMFONY', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '30.1', 'ciLowerLimit': '12.54', 'ciUpperLimit': '46.68', 'estimateComment': 'VIVITY minus AT LARA', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'AAS with data at Month 3 postoperative visit'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery'}, {'id': 'OG001', 'title': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery'}, {'id': 'OG002', 'title': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '35.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-2.3', 'ciLowerLimit': '-21.91', 'ciUpperLimit': '17.42', 'estimateComment': 'VIVITY minus SYMFONY', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '8.2', 'ciLowerLimit': '-12.00', 'ciUpperLimit': '27.80', 'estimateComment': 'VIVITY minus AT LARA', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'AAS with data at Month 3 postoperative visit'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery'}, {'id': 'OG001', 'title': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery'}, {'id': 'OG002', 'title': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '38.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '23.5', 'ciLowerLimit': '4.66', 'ciUpperLimit': '40.86', 'estimateComment': 'VIVITY minus SYMFONY', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '40.7', 'ciLowerLimit': '21.16', 'ciUpperLimit': '57.22', 'estimateComment': 'VIVITY minus AT LARA', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'AAS with data at Month 3 postoperative visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery'}, {'id': 'FG001', 'title': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery'}, {'id': 'FG002', 'title': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'First Eye Implanted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'Second Eye Implanted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sick . Could not attend visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand.', 'preAssignmentDetails': 'Of the 222 enrolled, 24 subjects were exited as screen failures prior to randomization. Of the 198 subjects randomized, both eyes from five subjects and second eyes from 2 subjects (i.e., 5 first eyes, 7 second eyes) were discontinued after randomization and prior to attempted implantation. This reporting group includes all randomized and implanted subjects (193).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery'}, {'id': 'BG001', 'title': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery'}, {'id': 'BG002', 'title': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '8.07', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '9.25', 'groupId': 'BG001'}, {'value': '66.1', 'spread': '8.60', 'groupId': 'BG002'}, {'value': '66.7', 'spread': '8.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White (Caucasian)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Indigenous or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Implanted Analysis Set (AAS): All eyes with successful study IOL implantation in one or more eye.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-18', 'size': 2507114, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-29T10:37', 'hasProtocol': True}, {'date': '2021-05-12', 'size': 999312, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-29T08:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2019-09-19', 'resultsFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-02', 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.'}, {'measure': 'Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)', 'timeFrame': 'Month 3 postoperative (Day 120-180 from second eye surgery)', 'description': 'A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataracts', 'Extracapsular cataract extraction', 'IOL', 'Extended depth of focus', 'Visual disturbances', 'Presbyopia', 'Intraocular lens'], 'conditions': ['Aphakia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.', 'detailedDescription': 'A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned cataract removal in both eyes.\n* Willing and able to complete all required postoperative visits.\n* Able to understand, read and write English and willing to sign an approved statement of informed consent.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.\n* Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.\n* Ocular trauma or ocular surface disease that would affect study measurements.\n* Patients who desire monovision correction.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04098367', 'briefTitle': 'Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs', 'orgStudyIdInfo': {'id': 'ILI875-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIVITY', 'description': 'VIVITY IOL implanted in the eye during cataract surgery', 'interventionNames': ['Device: VIVITY', 'Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SYMFONY', 'description': 'SYMFONY IOL implanted in the eye during cataract surgery', 'interventionNames': ['Device: SYMFONY', 'Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AT LARA', 'description': 'AT LARA implanted in the eye during cataract surgery', 'interventionNames': ['Device: AT LARA', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'VIVITY', 'type': 'DEVICE', 'otherNames': ['AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015'], 'description': 'Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction', 'armGroupLabels': ['VIVITY']}, {'name': 'SYMFONY', 'type': 'DEVICE', 'otherNames': ['TECNIS Symfony® Extended Range of Vision IOL Model ZXR00'], 'description': 'Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed', 'armGroupLabels': ['SYMFONY']}, {'name': 'AT LARA', 'type': 'DEVICE', 'otherNames': ['AT LARA® extended depth of focus IOL Model 829MP'], 'description': 'Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction', 'armGroupLabels': ['AT LARA']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Cataract removal by routine small incision surgery', 'armGroupLabels': ['AT LARA', 'SYMFONY', 'VIVITY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2290', 'city': 'Charlestown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Alcon Investigator 8047', 'geoPoint': {'lat': -32.96828, 'lon': 151.69318}}, {'zip': '2067', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Alcon Investigator 6667', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2150', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Alcon Investigator 7678', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5063', 'city': 'Eastwood', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Alcon Investigator 8052', 'geoPoint': {'lat': -34.94234, 'lon': 138.62176}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Alcon Investigator 7130', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3040', 'city': 'Essendon', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alcon Investigator 8010', 'geoPoint': {'lat': -37.74981, 'lon': 144.9109}}, {'zip': '3011', 'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alcon Investigator 7813', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'zip': '3931', 'city': 'Mornington', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alcon Investigator 1702', 'geoPoint': {'lat': -38.21792, 'lon': 145.03876}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Alcon Investigator 8051', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '1050', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Alcon Investigator 8056', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Alcon Investigator 8050', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '6011', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Alcon Investigator 3656', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}