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Ignite Creation Date: 2025-12-24 @ 7:43 PM

Ignite Modification Date: 2026-02-12 @ 4:18 AM

Study NCT ID: NCT03350503

Status: COMPLETED

Last Update Posted: 2022-12-28

First Post: 2017-11-16

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: AcrySof IQ Toric A-Code Post-Market Clinical Study

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Expert Clinical Project Lead, CDMA Surgical', 'organization': 'Alcon Research'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported for the duration of individual participation (up to 990-1140 days).', 'description': 'Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted implantation of the test article (successful or aborted after contact with the eye).', 'eventGroups': [{'id': 'EG000', 'title': 'Acrysof IQ Toric A-code IOL', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted unilaterally', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 7, 'seriousNumAtRisk': 121, 'deathsNumAffected': 4, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemmorhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dermatochalasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}, {'units': 'eye', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acrysof IQ Toric A-code IOL', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'Less than 10 degrees rotation', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}, {'title': 'Greater than or equal to 10 degrees rotation', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Less than 20 degrees rotation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Greater than or equal to 20 degrees rotation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Less than 30 degrees rotation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Greater than or equal to 30 degrees rotation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at Visit 4.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '90', 'groupId': 'OG007'}]}, {'units': 'eye', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '90', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 00 (Day 0 Operative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'Less than 10 degrees rotation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '99.2', 'groupId': 'OG002'}, {'value': '99.1', 'groupId': 'OG003'}, {'value': '99.1', 'groupId': 'OG004'}, {'value': '99.1', 'groupId': 'OG005'}, {'value': '98.9', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}]}]}, {'title': 'Greater than or equal to 10 degrees rotation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0.9', 'groupId': 'OG003'}, {'value': '0.9', 'groupId': 'OG004'}, {'value': '0.9', 'groupId': 'OG005'}, {'value': '1.1', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Less than 20 degrees rotation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}]}]}, {'title': 'Greater than or equal to 20 degrees rotation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Less than 30 degrees rotation', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}]}]}, {'title': 'Greater than or equal to 30 degrees rotation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Absolute Value of IOL Rotation From Visit 00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '90', 'groupId': 'OG007'}]}, {'units': 'eye', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '90', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 00 (Day 0 Operative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '2.30', 'spread': '2.23', 'groupId': 'OG004'}, {'value': '2.10', 'spread': '2.08', 'groupId': 'OG005'}, {'value': '2.31', 'spread': '1.99', 'groupId': 'OG006'}, {'value': '2.10', 'spread': '2.06', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.', 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation and measurable data at both visits.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '115', 'groupId': 'OG005'}, {'value': '109', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}, {'units': 'eye', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '115', 'groupId': 'OG005'}, {'value': '109', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 0 (Preoperative)', 'description': 'Prior to AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '0.551', 'spread': '0.368', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.170', 'groupId': 'OG001'}, {'value': '0.058', 'spread': '0.156', 'groupId': 'OG002'}, {'value': '0.040', 'spread': '0.127', 'groupId': 'OG003'}, {'value': '0.054', 'spread': '0.149', 'groupId': 'OG004'}, {'value': '0.045', 'spread': '0.163', 'groupId': 'OG005'}, {'value': '0.070', 'spread': '0.157', 'groupId': 'OG006'}, {'value': '0.086', 'spread': '0.182', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '115', 'groupId': 'OG005'}, {'value': '109', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}, {'units': 'eye', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '115', 'groupId': 'OG005'}, {'value': '109', 'groupId': 'OG006'}, {'value': '104', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 0 (Preoperative)', 'description': 'Prior to AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '0.190', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '-0.030', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-0.063', 'spread': '0.088', 'groupId': 'OG002'}, {'value': '-0.080', 'spread': '0.063', 'groupId': 'OG003'}, {'value': '-0.075', 'spread': '0.099', 'groupId': 'OG004'}, {'value': '-0.085', 'spread': '0.077', 'groupId': 'OG005'}, {'value': '-0.073', 'spread': '0.080', 'groupId': 'OG006'}, {'value': '-0.069', 'spread': '0.101', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}]}, {'units': 'eye', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '4.50', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '4.50', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '4.48', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '4.64', 'spread': '0.78', 'groupId': 'OG004'}, {'value': '4.82', 'spread': '0.63', 'groupId': 'OG005'}, {'value': '5.11', 'spread': '0.76', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean SSNG Densitometry (Area Analysis) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}]}, {'units': 'eye', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '107', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '4.08', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '4.05', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '4.19', 'spread': '0.38', 'groupId': 'OG004'}, {'value': '4.30', 'spread': '0.41', 'groupId': 'OG005'}, {'value': '4.45', 'spread': '0.48', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'All Implanted Analysis Set: All eyes with successful test article implantation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Device Deficiencies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'eye', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'Broken IOL optic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Broken IOL haptic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'IOL luxation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'IOL dislocation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other: IOL rotation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance.', 'unitOfMeasure': 'device deficiency', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'Safety Analysis Set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Eyes With Glistening by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}]}, {'units': 'eye', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '88.0', 'groupId': 'OG003'}, {'value': '68.1', 'groupId': 'OG004'}, {'value': '59.4', 'groupId': 'OG005'}, {'value': '49.0', 'groupId': 'OG006'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '9.4', 'groupId': 'OG003'}, {'value': '20.7', 'groupId': 'OG004'}, {'value': '21.8', 'groupId': 'OG005'}, {'value': '27.9', 'groupId': 'OG006'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '2.6', 'groupId': 'OG003'}, {'value': '7.8', 'groupId': 'OG004'}, {'value': '13.9', 'groupId': 'OG005'}, {'value': '15.4', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '3.4', 'groupId': 'OG004'}, {'value': '5.0', 'groupId': 'OG005'}, {'value': '7.7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Eyes With Posterior Capsule Opacification (PCO) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}]}, {'units': 'eye', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Unscheduled Visits Between Visit 1 and Visit 7', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG008', 'title': 'Visit 1 Through Visit 7 Cumulative', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '74', 'groupId': 'OG008'}]}]}, {'title': 'Clinically nonsignificant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '39', 'groupId': 'OG008'}]}]}, {'title': 'Clinically significant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Clinically significant requiring Nd:YAG laser treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7', 'description': 'A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator.', 'unitOfMeasure': 'eye', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}]}, {'units': 'eye', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 (Day 1-2 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG001', 'title': 'Visit 2 (Day 7-14 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG002', 'title': 'Visit 3 (Day 30-60 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG003', 'title': 'Visit 4 (Day 120-180 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG004', 'title': 'Visit 5 (Day 330-420 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG005', 'title': 'Visit 6 (Day 630-780 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG006', 'title': 'Visit 7 (Day 990-1140 Postoperative)', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG007', 'title': 'Unscheduled Visits Between Visit 1 and Visit 7', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}, {'id': 'OG008', 'title': 'Visit 1 Through Visit 7 Cumulative', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '116', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}, {'value': '103', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '116', 'groupId': 'OG008'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7', 'description': 'A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded.', 'unitOfMeasure': 'eye', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'Safety Analysis Set: All eyes with attempted implantation with the test article (successful or aborted after contact with the eye). Note: One subject implanted with the test article discontinued the study prior to the Visit 1 assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AcrySof IQ Toric A-code IOL', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '121', 'numSubjects': '121'}]}, {'type': 'Successful Implantation', 'achievements': [{'groupId': 'FG000', 'numUnits': '120', 'numSubjects': '120'}]}, {'type': 'Implanted With SN6AT3', 'achievements': [{'groupId': 'FG000', 'numUnits': '61', 'numSubjects': '61'}]}, {'type': 'Implanted With SN6AT4', 'achievements': [{'groupId': 'FG000', 'numUnits': '27', 'numSubjects': '27'}]}, {'type': 'Implanted With SN6AT5', 'achievements': [{'groupId': 'FG000', 'numUnits': '33', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '104', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '17', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Continuation impossible due to move', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'eye', 'recruitmentDetails': 'Subjects were enrolled at 4 investigative sites located in Japan.', 'preAssignmentDetails': 'Of the 125 subjects enrolled, 4 were exited as screen failures prior to implantation with the test article. This reporting group includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye) (Safety Analysis Set).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Acrysof IQ Toric A-code IOL', 'description': 'AcrySof IQ Toric A-code (SN6AT3 - SN6AT5) implanted in the study eye'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than 60 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '60 to 69 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '70 to 79 years', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Equal to or greater than 80 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-16', 'size': 1344363, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-18T15:12', 'hasProtocol': True}, {'date': '2017-08-07', 'size': 1044351, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-18T15:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2017-11-16', 'resultsFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-01', 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Eyes With Absolute Value of IOL Rotation From Visit 00', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.'}, {'measure': 'Mean Absolute Value of IOL Rotation From Visit 00', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle on the IOL at the specified visit and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.'}, {'measure': 'Mean Uncorrected Distance Visual Acuity (UCDVA) by Visit', 'timeFrame': 'Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Visual acuity (VA) was tested under well-lit conditions with no refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.'}, {'measure': 'Mean Best Corrected Distance Visual Acuity (BCDVA) by Visit', 'timeFrame': 'Visit 0 (Preoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Visual acuity (VA) was tested under well-lit conditions with refractive correction in place using a decimal visual acuity chart set at 5 meters. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. A negative value denotes better than 20/20 visual acuity.'}, {'measure': 'Mean Sub-Surface Nano Glistening (SSNG) Densitometry (Peak) by Visit', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Peak value is the highest value in the IOL anterior surface light scattering densitometry.'}, {'measure': 'Mean SSNG Densitometry (Area Analysis) by Visit', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'Sub-surface nano glistening (SSNG) densitometry was measured as the IOL anterior surface light scattering densitometry using Pentacam or Pentacam HR. SSNG was measured in units specific to the device, with a higher number indicating a higher presence of SSNG. Area analysis value is an average value of the IOL anterior surface light scattering densitometry in a certain area.'}, {'measure': 'Number of Device Deficiencies', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 00-A (Day 0, 1 +/- 0.5 hours postoperative), Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'A device deficiency was defined as an inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety, or performance.'}, {'measure': 'Percentage of Eyes With Glistening by Visit', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140)', 'description': 'A slit lamp examination was conducted to determine the presence/absence of glistening particles on the implanted IOL. Glistening was reported by on a 4-point scale, where Grade 0 = no glistening; Grade 1 = mild glistening (50/mm3); Grade 2 = moderate glistening (100/mm3); and Grade 3 = severe glistening (200/mm3).'}, {'measure': 'Number of Eyes With Posterior Capsule Opacification (PCO) by Visit', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7', 'description': 'A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). The presence or absence of PCO was recorded. Clinical significance was determined by the investigator.'}, {'measure': 'Number of Eyes Receiving Nd:YAG Laser Treatment for Posterior Capsule Opacification (PCO) by Visit', 'timeFrame': 'Visit 1 (Day 1-2 postoperative), Visit 2 (Day 7-14), Visit 3 (Day 30-60), Visit 4 (Day 120-180), Visit 5 (Day 330-420), Visit 6 (Day 630-780), Visit 7 (Day 990-1140), Unscheduled Visits between Visit 1 and Visit 7', 'description': 'A slit lamp examination was performed to evaluate the eye for posterior capsule opacification (that is, the thickening, opacification and clouding of the posterior lens capsule). A neodymium-doped yttrium aluminum garnet (Nd:YAG) laser was used to treat posterior capsule opacification, with treatment determined by the investigator. The presence or absence of Nd:YAG laser treament was recorded.'}], 'primaryOutcomes': [{'measure': 'Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)', 'timeFrame': 'Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)', 'description': 'IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['phacoemulsification', 'intraocular lens', 'vision', 'toric'], 'conditions': ['Cataract', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.', 'detailedDescription': 'Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cataracts with planned cataract removal by phacoemulsification\n* Calculated lens power within the available range\n* Able to sign informed consent and complete all study visits\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye conditions as specified in the protocol\n* Uncontrolled glaucoma\n* Pregnancy, current or planned\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03350503', 'briefTitle': 'AcrySof IQ Toric A-Code Post-Market Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'AcrySof IQ Toric A-Code Post-Market Clinical Study', 'orgStudyIdInfo': {'id': 'ILV814-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acrysof IQ Toric A-code IOL', 'description': 'IOL implanted during cataract surgery', 'interventionNames': ['Device: AcrySof IQ Toric A-code IOL', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'AcrySof IQ Toric A-code IOL', 'type': 'DEVICE', 'otherNames': ['Models SN6AT3, SN6AT4, SN6AT5'], 'description': 'Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient', 'armGroupLabels': ['Acrysof IQ Toric A-code IOL']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Removal of cataractous lens and implantation of IOL', 'armGroupLabels': ['Acrysof IQ Toric A-code IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '733-0842', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '040-0053', 'city': 'Hakodate', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'zip': '885-0051', 'city': 'Miyakonojō', 'state': 'Miyazaki', 'country': 'Japan', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 31.73333, 'lon': 131.06667}}, {'zip': '840-0831', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}], 'overallOfficials': [{'name': 'Expert Clinical Project Lead, CDMA Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}