Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2026-01-01 @ 11:00 AM
Study NCT ID:
NCT03633695
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2018-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'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': 'D007910', 'term': 'Lenses, Intraocular'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmichna@acufocus.com', 'phone': '(949) 585-9511', 'title': 'Magda Michna, PhD., Chief Global Clinical, Medical and Regulatory Affairs Officer', 'organization': 'AcuFocus, Inc.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the PI must provide sponsor a manuscript of such submission(s) for review, comment and approval at least 90 days prior to a planned submission for publication or presentation and that sponsor is permitted to delay any publication or presentation in specific circumstances.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Second eye implantation through study completion; approximately 1-year (12 months).', 'description': 'Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).', 'eventGroups': [{'id': 'EG000', 'title': 'Preoperative', 'description': 'All subjects in the safety analysis population (Intent-to-Treat population) prior to second eye implantation.', 'otherNumAtRisk': 453, 'deathsNumAtRisk': 453, 'otherNumAffected': 0, 'seriousNumAtRisk': 453, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IC-8™ IOL Group - 2nd Eye', 'description': 'All second eyes (study eyes) implanted with IC-8™ IOL in the IC-8™ IOL Group.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 264, 'seriousNumAtRisk': 343, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'IC-8™ IOL Group - 1st Eye', 'description': 'All first eyes (fellow eyes) implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the IC-8™ IOL Group.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 148, 'seriousNumAtRisk': 343, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'IC-8™ IOL Group - Systemic', 'description': 'All subjects implanted with the IC-8™ IOL in the IC-8™ IOL Group.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 114, 'seriousNumAtRisk': 343, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG004', 'title': 'Control Group - 2nd Eye', 'description': 'All second eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 56, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Control Group - 1st Eye', 'description': 'All first eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 55, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Control Group - Systemic', 'description': 'All subjects implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 50, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute liver failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Altered Visual Depth Perception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anterior Capsular Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arteriosclerosis/Atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia/Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchospasm/Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Brow, Eyelid Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cataract Fragments in Eye Following Cataract Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cataract Operation Complication, Lens Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cataract Subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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{'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Solid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Intraocular Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Iris Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Retinal Vein Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.051', 'spread': '0.1629', 'groupId': 'OG000'}, {'value': '0.228', 'spread': '0.1646', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.177', 'ciLowerLimit': '-0.214', 'ciUpperLimit': '-0.140', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'estimateComment': 'Acuity Difference = IC-8 Group - Control Group', 'groupDescription': 'The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'PRIMARY', 'title': 'Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.186', 'spread': '0.1425', 'groupId': 'OG000'}, {'value': '0.377', 'spread': '0.1576', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.191', 'ciLowerLimit': '-0.223', 'ciUpperLimit': '-0.158', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'estimateComment': 'Acuity Difference = IC-8 Group - Control Group', 'groupDescription': 'The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'PRIMARY', 'title': 'Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.1063', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0992', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciUpperLimit': '0.007', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'estimateComment': 'Acuity Difference = IC-8 IOL Group - Control Group', 'groupDescription': 'The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority margin was 0.1 logMAR.'}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'PRIMARY', 'title': 'Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.144', 'spread': '0.1709', 'groupId': 'OG000'}, {'value': '0.325', 'spread': '0.1687', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.180', 'ciLowerLimit': '-0.198', 'ciUpperLimit': '-0.163', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'estimateComment': 'Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)', 'groupDescription': 'The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'PRIMARY', 'title': 'Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': 'NA', 'comment': 'The negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': 'NA', 'comment': 'The negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in depth of focus', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.91', 'estimateComment': 'Difference in depth of focus \\[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\\]', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 Months (60-110 days post second eye operative visit)', 'description': 'Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation.', 'unitOfMeasure': 'Diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'PRIMARY', 'title': 'Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.009', 'spread': '0.1131', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.0928', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciUpperLimit': '0.082', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'estimateComment': 'Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)', 'groupDescription': 'The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was 0.1 logMAR.'}], 'paramType': 'MEAN', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the Best-Case analysis was used, which, included subjects with no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors (as defined by ISO 11979-1:2012), as well as no significant macular pathology at any time. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Cystoid Macular Edema', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypopyon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Endophthalmitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lens Dislocated from Posterior Chamber', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pupillary Block', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Retinal Detachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Modified Paracentesis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Intravitreal Injection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Laser Retinopexy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other: Retinal Vein Occlusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitrectomy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Removal of retained cortex', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'IOL repositioning', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}, {'units': 'Eyes', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8 IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'OG002', 'title': 'Second Eyes (Control Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'OG003', 'title': 'First Eyes (Control Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Intravitreal Injection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'IOL Exchange', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'IOL Repositioning', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Iris Reposition', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Laser Retinopexy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Laser Vitreolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Modified Paracentesis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Removal of Retained Cortex', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vitrectomy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Corneal Stromal Edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cystoid Macular Edema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Iritis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Raised IOP Requiring Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other: Retinal Vein Occlusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}, {'units': 'Eyes', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'OG002', 'title': 'Second Eye (Control Group)', 'description': 'Eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.'}, {'id': 'OG003', 'title': 'First Eye (Control Group)', 'description': 'Eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}, {'units': 'Eyes', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8 IOL Eyes (IC-8™ IOL Group', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'OG002', 'title': 'Second Eyes (Control Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'OG003', 'title': 'First Eyes (Control Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Device Damage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Posterior Capsule Opacification', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Altered Visual Depth Perception', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dysphotopsia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Halo Vision', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vision Blurred', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes With Astigmatism <1.0 D (IC-8™ IOL Group)', 'description': 'Eyes with \\<1.0 D preoperative corneal astigmatism implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'IC-8™ IOL Eyes With Astigmatism 1.0 D - 1.5 D (IC-8™ IOL Group)', 'description': 'Eyes with 1.0 D - 1.5 D preoperative corneal astigmatism implanted with the IC-8™ Intraocular Lens (IOL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.085', 'spread': '0.1269', 'groupId': 'OG000'}, {'value': '0.108', 'spread': '0.1208', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.023', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority margin was 0.12 logMAR.'}], 'paramType': 'MEAN', 'timeFrame': '3 Months (60-110 days post second eye operative visit)', 'description': 'Uncorrected-distance visual acuity (UCDVA) in IC-8™ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism \\< 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'For this outcome measure, the number of participants/eyes from the modified Intent-to-Treat (mITT) population (subjects from the intent to treat population that achieved BCDVA 20/25 or better) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.'}, {'type': 'SECONDARY', 'title': 'Mean Monocular Photopic Contrast Sensitivity Without Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.935', 'spread': '0.3768', 'groupId': 'OG000'}, {'value': '2.202', 'spread': '0.2542', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.795', 'spread': '0.3736', 'groupId': 'OG000'}, {'value': '2.055', 'spread': '0.3576', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '1.308', 'spread': '0.4186', 'groupId': 'OG000'}, {'value': '1.554', 'spread': '0.4530', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 18 cpd', 'categories': [{'measurements': [{'value': '0.832', 'spread': '0.3996', 'groupId': 'OG000'}, {'value': '1.072', 'spread': '0.4220', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Monocular Photopic Contrast Sensitivity With Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.620', 'spread': '0.4219', 'groupId': 'OG000'}, {'value': '1.822', 'spread': '0.4247', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.513', 'spread': '0.3926', 'groupId': 'OG000'}, {'value': '1.747', 'spread': '0.4136', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '1.106', 'spread': '0.4149', 'groupId': 'OG000'}, {'value': '1.345', 'spread': '0.4315', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 18 cpd', 'categories': [{'measurements': [{'value': '0.659', 'spread': '0.4161', 'groupId': 'OG000'}, {'value': '0.887', 'spread': '0.4171', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Monocular Mesopic Contrast Sensitivity Without Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 1.5 cpd', 'categories': [{'measurements': [{'value': '1.385', 'spread': '0.3596', 'groupId': 'OG000'}, {'value': '1.850', 'spread': '0.3849', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.475', 'spread': '0.3882', 'groupId': 'OG000'}, {'value': '1.964', 'spread': '0.3662', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.217', 'spread': '0.3901', 'groupId': 'OG000'}, {'value': '1.609', 'spread': '0.4300', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '0.620', 'spread': '0.3739', 'groupId': 'OG000'}, {'value': '0.913', 'spread': '0.4105', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Monocular Mesopic Contrast Sensitivity With Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with the IC-8™ Intraocular Lens (IOL).'}, {'id': 'OG001', 'title': 'Fellow Eyes (IC-8™ IOL Group)', 'description': 'Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 1.5 cpd', 'categories': [{'measurements': [{'value': '1.044', 'spread': '0.4063', 'groupId': 'OG000'}, {'value': '1.338', 'spread': '0.4212', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.201', 'spread': '0.4142', 'groupId': 'OG000'}, {'value': '1.552', 'spread': '0.4468', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.035', 'spread': '0.4337', 'groupId': 'OG000'}, {'value': '1.353', 'spread': '0.4224', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '0.496', 'spread': '0.3886', 'groupId': 'OG000'}, {'value': '0.749', 'spread': '0.4305', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binocular Photopic Contrast Sensitivity Without Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '2.233', 'spread': '0.2536', 'groupId': 'OG000'}, {'value': '2.287', 'spread': '0.1896', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '2.119', 'spread': '0.3293', 'groupId': 'OG000'}, {'value': '2.141', 'spread': '0.3177', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '1.689', 'spread': '0.4263', 'groupId': 'OG000'}, {'value': '1.654', 'spread': '0.5124', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 18 cpd', 'categories': [{'measurements': [{'value': '1.164', 'spread': '0.4123', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.4834', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binocular Photopic Contrast Sensitivity With Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.866', 'spread': '0.3893', 'groupId': 'OG000'}, {'value': '1.983', 'spread': '0.3217', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.856', 'spread': '0.3853', 'groupId': 'OG000'}, {'value': '1.891', 'spread': '0.3745', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '1.431', 'spread': '0.4408', 'groupId': 'OG000'}, {'value': '1.476', 'spread': '0.4720', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 18 cpd', 'categories': [{'measurements': [{'value': '0.957', 'spread': '0.4388', 'groupId': 'OG000'}, {'value': '0.970', 'spread': '0.4516', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binocular Mesopic Contrast Sensitivity Without Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 1.5 cpd', 'categories': [{'measurements': [{'value': '1.936', 'spread': '0.3442', 'groupId': 'OG000'}, {'value': '1.969', 'spread': '0.4236', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '2.030', 'spread': '0.3306', 'groupId': 'OG000'}, {'value': '2.079', 'spread': '0.3129', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.688', 'spread': '0.3922', 'groupId': 'OG000'}, {'value': '1.723', 'spread': '0.4132', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '0.995', 'spread': '0.4098', 'groupId': 'OG000'}, {'value': '0.986', 'spread': '0.4300', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binocular Mesopic Contrast Sensitivity With Glare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'units': 'log units', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}], 'classes': [{'title': 'Spatial Frequency 1.5 cpd', 'categories': [{'measurements': [{'value': '1.395', 'spread': '0.4280', 'groupId': 'OG000'}, {'value': '1.559', 'spread': '0.3979', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 3 cpd', 'categories': [{'measurements': [{'value': '1.602', 'spread': '0.4527', 'groupId': 'OG000'}, {'value': '1.714', 'spread': '0.3955', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 6 cpd', 'categories': [{'measurements': [{'value': '1.382', 'spread': '0.4254', 'groupId': 'OG000'}, {'value': '1.403', 'spread': '0.3575', 'groupId': 'OG001'}]}]}, {'title': 'Spatial Frequency 12 cpd', 'categories': [{'measurements': [{'value': '0.797', 'spread': '0.3951', 'groupId': 'OG000'}, {'value': '0.756', 'spread': '0.4223', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.", 'unitOfMeasure': 'log units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'log units', 'denomUnitsSelected': 'log units', 'populationDescription': 'A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.\n\n* Subjects in this Group were assigned to Astigmatism Group 1 (\\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (study eye).'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).\n\n* Subjects in this Group were assigned to Astigmatism Group 1 (\\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (fellow eye).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '686', 'numSubjects': '343'}, {'groupId': 'FG001', 'numUnits': '220', 'numSubjects': '110'}]}, {'type': 'Astigmatism Group 1 (IC-8™ IOL Group)', 'achievements': [{'groupId': 'FG000', 'numUnits': '546', 'numSubjects': '273'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Astigmatism Group 2 (IC-8™ IOL Group)', 'achievements': [{'groupId': 'FG000', 'numUnits': '140', 'numSubjects': '70'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Astigmatism Group 1 (Control Group)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '182', 'numSubjects': '91'}]}, {'type': 'Astigmatism Group 2 (Control Group)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '38', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '662', 'numSubjects': '331'}, {'groupId': 'FG001', 'numUnits': '202', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '12'}, {'groupId': 'FG001', 'numUnits': '18', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'Subjects were recruited from 21 investigative sites within the United States from 04 December 2018 to 21 August 2019. The investigative sites were comprised of similar clinic, surgical center, and equipment requirements necessary for the intended use of the IC-8™ IOL.', 'preAssignmentDetails': 'A total of 548 subjects signed the informed consent form, 79 of whom did not meet inclusion/exclusion criteria and were considered screen failures; leaving 469 subjects who were considered provisionally enrolled in the study. A total of 16 subjects were disqualified or discontinued from the study prior to second eye implantation. There were 453 subjects who were successfully bilaterally implanted in the study (reporting group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IC-8™ IOL Group', 'description': 'Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '7.96', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '8.63', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '8.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '311', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Entries of 'Unknown' or 'Not Reported' represent race reported as 'Other'. During the clinical study there were no participants with 'Unknown' or 'Not Reported' race.", 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative Corneal Astigmatism', 'classes': [{'title': 'Astigmatism Group 1 (<1.0 D)', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}]}, {'title': 'Astigmatism Group 2 (1.0 D - 1.5 D)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each study group (IC-8™ IOL Group, Control Group) included two astigmatism groups, Astigmatism Group 1 (\\<1.0 D) and Astigmatism Group 2 (1.0 D - 1.5 D). The enrollment ratio was approximately 5:1 for Astigmatism Group 1 vs. Astigmatism Group 2. Subject assignment to Astigmatism Group 1 or Astigmatism Group 2 was determined by preoperative corneal astigmatism in the second eye as measured by optical biometry.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population includes all eyes with successful bilateral implantation (Intent-to-Treat analysis population). Baseline characteristics were analyzed by subject.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-23', 'size': 1607676, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-21T10:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Examiner masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2018-08-14', 'resultsFirstSubmitDate': '2022-08-21', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-23', 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes', 'timeFrame': '3 Months (60-110 days post second eye operative visit)', 'description': 'Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation.'}, {'measure': 'Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.'}, {'measure': 'Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates', 'timeFrame': '12 Months (300-420 days post second eye operative visit)', 'description': 'Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.'}, {'measure': 'Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.'}, {'measure': 'Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.'}, {'measure': 'Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.'}, {'measure': 'Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.'}, {'measure': 'Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)', 'timeFrame': 'Through 12 Months (300-420 days post second eye operative visit)', 'description': 'The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.'}], 'secondaryOutcomes': [{'measure': 'Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months', 'timeFrame': '3 Months (60-110 days post second eye operative visit)', 'description': 'Uncorrected-distance visual acuity (UCDVA) in IC-8™ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism \\< 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.'}, {'measure': 'Mean Monocular Photopic Contrast Sensitivity Without Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value."}, {'measure': 'Mean Monocular Photopic Contrast Sensitivity With Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Monocular Mesopic Contrast Sensitivity Without Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Monocular Mesopic Contrast Sensitivity With Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Binocular Photopic Contrast Sensitivity Without Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Binocular Photopic Contrast Sensitivity With Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Binocular Mesopic Contrast Sensitivity Without Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}, {'measure': 'Mean Binocular Mesopic Contrast Sensitivity With Glare', 'timeFrame': '6 Months (160-210 days post second eye operative visit)', 'description': "Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cataract', 'Intraocular lens'], 'conditions': ['Cataract', 'Presbyopia']}, 'referencesModule': {'references': [{'pmid': '39075732', 'type': 'DERIVED', 'citation': 'Vukich J, Thompson V, Yeu E, Wiley WF, Bafna S, Koch DD, Lin L, Michna M. Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism in visual performance. J Cataract Refract Surg. 2024 Nov 1;50(11):1165-1172. doi: 10.1097/j.jcrs.0000000000001524.'}], 'seeAlsoLinks': [{'url': 'http://www.acufocus.com', 'label': 'Sponsor website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.', 'detailedDescription': 'Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Minimum 22 years of age;\n2. Able to comprehend and have signed a statement of informed consent;\n3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;\n4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;\n5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;\n6. Potential for postoperative BCDVA of 20/25 or better in each eye\n7. Clear intraocular media, other than cataract.\n\nExclusion Criteria:\n\n1. Requiring an IC-8 intraocular lens outside the available spherical power range\n2. Pharmacologically dilated pupil size less than 6 mm in either eye;\n3. Inability to achieve stable keratometric readings for contact lens wearers\n4. Irregular astigmatism in either eye;\n5. Preoperative corneal astigmatism \\> 1.50 diopters in either eye\n6. Active or recurrent anterior segment pathology\n7. Presence of ocular abnormalities other than cataract as specified in the protocol\n8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;\n9. Congenital cataracts;\n10. Previous corneal or intraocular surgery\n11. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;\n12. Systemic conditions as specified in the protocol;\n13. Patient is pregnant, plans to become pregnant, or is lactating\n14. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.'}, 'identificationModule': {'nctId': 'NCT03633695', 'briefTitle': 'Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'AcuFocus, Inc.'}, 'officialTitle': 'Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens', 'orgStudyIdInfo': {'id': 'SAIL-101-UNI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IC-8 IOL Group', 'description': 'A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye.', 'interventionNames': ['Device: IC-8 IOL Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.', 'interventionNames': ['Device: Control Group']}], 'interventions': [{'name': 'IC-8 IOL Group', 'type': 'DEVICE', 'otherNames': ['Intraocular Lens'], 'description': 'A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.', 'armGroupLabels': ['IC-8 IOL Group']}, {'name': 'Control Group', 'type': 'DEVICE', 'otherNames': ['Intraocular lens'], 'description': 'A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye & Laser Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Harvard Eye Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '94024', 'city': 'Los Altos', 'state': 'California', 'country': 'United States', 'facility': 'Altos Eye Physicians', 'geoPoint': {'lat': 37.38522, 'lon': -122.11413}}, {'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Vision Care', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Center of Northern Colorado', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Center of North Florida', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '55420', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Chu Vision Institute', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pepose Vision Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68118', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Kugler Vision', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '12603', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Alterman, Modi & Wolter', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Physicians Protocol', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Eye Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18702', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bucci Laser Vision', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkhurst NuVision', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84021', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Hoopes Vision', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Eye Centers', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Magda Michna, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AcuFocus, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AcuFocus, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}