Viewing Study NCT01497067

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 12:34 AM
Ignite Modification Date: 2026-03-05 @ 2:46 PM
Study NCT ID: NCT01497067
Status: COMPLETED
Last Update Posted: 2019-07-02
First Post: 2011-12-20
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
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': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. Clinical Trial Lead, 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 were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment.', 'description': 'Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.', 'eventGroups': [{'id': 'EG000', 'title': 'CACHET - Ocular', 'description': 'All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series)', 'otherNumAtRisk': 1123, 'deathsNumAtRisk': 1123, 'otherNumAffected': 0, 'seriousNumAtRisk': 1123, 'deathsNumAffected': 0, 'seriousNumAffected': 276}, {'id': 'EG001', 'title': 'CACHET - Systemic', 'description': 'All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series)', 'otherNumAtRisk': 657, 'deathsNumAtRisk': 657, 'otherNumAffected': 0, 'seriousNumAtRisk': 657, 'deathsNumAffected': 3, 'seriousNumAffected': 24}], 'seriousEvents': [{'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract cortical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Choroidal neovascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Corneal endothelial cell loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exophthalmos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iris adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iris atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iris disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lens discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lens dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lenticular opacities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Open angle glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pupillary deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dislocation of vertebra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual acuity tests abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Throat cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Corneal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glaucoma surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intra-ocular injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraocular lens extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraocular lens implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraocular lens repositioning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iridotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iris operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Keratomileusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lens extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal laser coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinopexy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scleral buckling surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Trabeculectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Trabeculoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 657, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Central Endothelial Cell Density (All Eyes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '1123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CACHET', 'description': 'ACRYSOF CACHET Phakic Lens (L-series) previously implanted'}], 'classes': [{'title': 'Year 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2654.0', 'spread': '354.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2639.0', 'spread': '324.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 5.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2633.0', 'spread': '357.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2551.0', 'spread': '362.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 6.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2524.7', 'spread': '360.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '803', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2504.9', 'spread': '365.8', 'groupId': 'OG000'}]}]}, {'title': 'Year 7.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '726', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2497.1', 'spread': '364.7', 'groupId': 'OG000'}]}]}, {'title': 'Year 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '884', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2465.0', 'spread': '384.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 8.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '780', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2457.7', 'spread': '363.0', 'groupId': 'OG000'}]}]}, {'title': 'Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '856', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2409.6', 'spread': '388.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 9.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '825', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2399.3', 'spread': '387.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '872', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2377.5', 'spread': '398.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)', 'description': 'A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.', 'unitOfMeasure': 'cells/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CACHET', 'description': 'ACRYSOF CACHET Phakic Lens (L-series) previously implanted'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '657'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '575'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Patient decision unrel to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'This study enrolled subjects at 20 investigative sites located in the US, 9 investigative sites located in the European Union, and 5 investigative sites located in Canada.', 'preAssignmentDetails': 'This reporting group includes all enrolled subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CACHET', 'description': 'ACRYSOF CACHET Phakic Lens (L-series) previously implanted'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '448', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '209', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '597', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-05', 'size': 241028, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-08T12:49', 'hasProtocol': False}, {'date': '2013-04-18', 'size': 507337, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-08T15:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2011-12-20', 'resultsFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-03', 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Endothelial Cell Density (All Eyes)', 'timeFrame': 'Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)', 'description': 'A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Phakic Lens', 'Intraocular Lens (IOL)'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.', 'detailedDescription': 'Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).\n* Able to understand and sign a statement of informed consent.\n* Willing and able to complete the yearly postoperative study visits.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01497067', 'briefTitle': 'Long Term Safety Protocol for the AcrySof CACHET Phakic Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57', 'orgStudyIdInfo': {'id': 'C-09-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CACHET', 'description': 'ACRYSOF CACHET Phakic Lens (L-series) previously implanted', 'interventionNames': ['Device: ACRYSOF CACHET Phakic Lens (L-series)']}], 'interventions': [{'name': 'ACRYSOF CACHET Phakic Lens (L-series)', 'type': 'DEVICE', 'otherNames': ['AcrySof Angle-Supported Phakic Lens'], 'description': 'Intraocular lens for the treatment of moderate to high myopia', 'armGroupLabels': ['CACHET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Sr. Project Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}