Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00407602
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2006-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Argus® II Retinal Stimulation System Feasibility Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdorn@secondsight.com', 'phone': '8188335089', 'title': 'Jessy Dorn, PhD, Director of Clinical and Scientific Affiars', 'organization': 'Second Sight Medical Products, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 years', 'description': 'Ocular events are reportable for this protocol from day of implant through the last study visit for each subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'Single arm with fellow eye as comparator', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 28, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': '360 Circumferential Vitreous Band Traction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Choroidal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Choroidal effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis - inflammatory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal epithelial defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal fold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Suture Broken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal vascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decrease in light perception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective revision surgery', 'notes': 'Better placement of array on retina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epiphora', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epiretinal membrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrosis around retinal tack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Filamentary keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign Body Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Adjudicated as device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'High IOP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation - ocular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular pupil', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratic Precipitates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Adjudicated as device or procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nystagmus increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular fibrin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - ocular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 18, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-retinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Proliferative Vitreoretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Break/Tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment - tractional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal folds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Thickening - cystoid macular edema (CME)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Thickening - without cystic changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinoschisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision Surgery - tack replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rubeosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scleral graft displacement or reabsorption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suture irritation', 'notes': 'Associated with surgical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Conjunctival dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal melt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endophthalmitis - infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epiretinal membrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iris rubeosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratitis - infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration (extra-ocular) of intraocular silicone oil', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Re-tack', 'notes': 'Re-tack to hold the device in place on the retina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment - rhegmatogenous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment - tractional and serous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Only one arm in this study, treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': 'Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Single arm with fellow eye as comparator'}], 'classes': [{'title': 'Total number of subjects with serious ocular AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Total number of subjects with non-serious ocular AEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 years', 'description': 'Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Massof Activity Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nImplant of Argus II Retinal Prosthesis: epiretinal implantation of device'}], 'classes': [{'title': 'Subject1-Goals', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-.87', 'upperLimit': '0.67'}]}]}, {'title': 'S2-Goals', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.82'}]}]}, {'title': 'S3-Goals', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '0.93'}]}]}, {'title': 'S4-Goals', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.87'}]}]}, {'title': 'S5-Goals', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '0.96'}]}]}, {'title': 'S6-Goals', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '0.4'}]}]}, {'title': 'S7-Goals', 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-2.32', 'upperLimit': '-0.88'}]}]}, {'title': 'S8-Goals', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '1.59'}]}]}, {'title': 'S9-Goals', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.65'}]}]}, {'title': 'S10-Goals', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.86', 'upperLimit': '0.26'}]}]}, {'title': 'S11-Goals', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '0.71'}]}]}, {'title': 'S12-Goals', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.57', 'upperLimit': '0.57'}]}]}, {'title': 'S13-Goals', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '1.16'}]}]}, {'title': 'S14 -Goals', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Error in test administration, data determined to be invalid.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'S1-Tasks', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.99'}]}]}, {'title': 'S2-Tasks', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.45', 'upperLimit': '0.05'}]}]}, {'title': 'S3-Tasks', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.64'}]}]}, {'title': 'S4-Tasks', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '0.26'}]}]}, {'title': 'S5-Tasks', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '1.06'}]}]}, {'title': 'S6-Tasks', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.46'}]}]}, {'title': 'S7-Tasks', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.81', 'upperLimit': '0.21'}]}]}, {'title': 'S8-Tasks', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.52', 'upperLimit': '2.48'}]}]}, {'title': 'S9-Tasks', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '1.69'}]}]}, {'title': 'S10-Tasks', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.71', 'upperLimit': '-0.09'}]}]}, {'title': 'S11-Tasks', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.45', 'upperLimit': '0.05'}]}]}, {'title': 'S12-Tasks', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.62', 'upperLimit': '0.02'}]}]}, {'title': 'S13-Tasks', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.51'}]}]}, {'title': 'S14-Tasks', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Error in test administration, data determined to be invalid.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).', 'unitOfMeasure': 'Logit scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all 14 US subjects analyzed'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Tasks for Daily Living', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nArgus II Retinal Stimulation System: epiretinal implantation of device'}], 'classes': [{'categories': [{'measurements': [{'value': '.6191', 'spread': '.2146', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '30 subjects were analyzed comparing Baseline visit to the last visit when VisQOL was performed.'}, {'type': 'SECONDARY', 'title': 'Orientation and Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Only one arm in this study, treatment arm.'}], 'classes': [{'title': 'Average % system ON-Door Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'Average % system OFF-Door Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Average % system ON-Line Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Average % system OFF-Line Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.', 'unitOfMeasure': 'percentage of successful trials', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all 14 US subjects analyzed'}, {'type': 'SECONDARY', 'title': 'Visual Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nArgus II Retinal Stimulation System: epiretinal implantation of device'}], 'classes': [{'title': 'SL - Number of subjects with significantly better with system ON', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'DOM - Number of subjects with significantly better with system ON', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': 'Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data available only on 13 of the 14 US subjects'}, {'type': 'SECONDARY', 'title': 'Stability of Implant - 5 Years Post Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nImplant of Argus II Retinal Prosthesis: epiretinal implantation of device'}], 'classes': [{'title': 'Stable position of array on Array position stable-no rotation', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Minor array rotation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Inconclusive data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all 14 US subjects analyzed'}, {'type': 'SECONDARY', 'title': 'Device Reliability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nArgus II Retinal Stimulation System: epiretinal implantation of device'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': 'Number of participants with functional devices 10 years post implant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nArgus II Retinal Stimulation System: epiretinal implantation of device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death - unrelated to device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Device explanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.\n\nArgus II Retinal Stimulation System: epiretinal implantation of device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-01-15', 'size': 1303699, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-09-24T18:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2006-12-01', 'resultsFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2006-12-01', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-02', 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '10 years', 'description': 'Grating Visual Acuity is performed at Baseline and at various timepoints throughout the study. As of the 10 year final testing, the total number of subjects that were able to score on the logMAR scale are indicated below. The device has a scale from 1.6 to 2.9 logMAR. Maximum likelihood estimation of visual acuity is based on BEST-PEST algorithm.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': '10 years', 'description': 'Evaluate ocular adverse events reported for all subjects from day of implant through 10 years of study participation'}], 'secondaryOutcomes': [{'measure': 'Massof Activity Inventory', 'timeFrame': '3 years', 'description': 'The Massof Activity Inventory measures changes in ability to perform activities of daily living in terms of Goals and Tasks in logits (log-odds units). A logit scale is an equal interval linear scale that represents probability values in terms of real numbers. There is no minimum or maximum scale used in this testing. In this case, a Rasch distribution (using an Andrich rating model) was used to find the maximum likelihood of difficulty of achieving Goals and Tasks, represented in logits. The change in mean logit value between baseline and the 36Month visit for each subject are provided below along with the 95% confidence interval (CI) for the change. A positive change in the Goals or Tasks score which is greater than 0.2 (with a CI less than the mean logit value), is interpreted as a clinically significant increase in functional ability (better outcome).'}, {'measure': 'Quality of Life - Tasks for Daily Living', 'timeFrame': '3 years', 'description': 'Quality of life is being measured using the VisQOL survey. This instrument, developed by researchers at the University of Melbourne, Australia, is a vision and quality of life-related utility measure intended to evaluate healthcare interventions for the visually impaired. The utility score is a preference-based measure of vision-related quality of life (Dimension 7 score (Health Dimension Score (1=Best, 0=Worst)). It measures subjective quality of life on a scale of 0 to 1, where 0 represents worst possible quality of life and 1 represents perfect quality of life.'}, {'measure': 'Orientation and Mobility', 'timeFrame': '5 years', 'description': 'Argus II System for orientation and mobility, each subject completed two tests (walking to a high-contrast "door" on the wall and following a straight line on the floor) at various timepoints throughout the study. Accuracy (percent of trials where the subject successfully reached the target) was measured with the device system ON and system OFF. Average % success rates across the analysis population are provided for each modality and for each test at the 60 month time point.'}, {'measure': 'Visual Function', 'timeFrame': '10 years', 'description': 'Square localization (SL) and Direction of Motion (DOM) testing performed at specific protocol intervals. SL tests ability of subjects to locate high-contrast square on black screen. DOM tests ability of subjects to determine the direction a white bar is moving over a black screen. Each test is performed with the system ON and then compared to performance with the system OFF. Number of subjects who performed significantly better with the system ON is indicated below.'}, {'measure': 'Stability of Implant - 5 Years Post Implant', 'timeFrame': '5 years', 'description': 'Stability of electrode array on the retina. Qualitative review of imaging: retinal and array landmarks compared from all time points post implant.'}, {'measure': 'Device Reliability', 'timeFrame': '10 years', 'description': 'Number of participants with functional devices 10 years post implant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['retinitis pigmentosa', 'device', 'retinal implant', 'retinal prosthesis', 'RP', 'outer retinal degeneration'], 'conditions': ['Retinitis Pigmentosa']}, 'referencesModule': {'references': [{'pmid': '22260934', 'type': 'BACKGROUND', 'citation': 'Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.'}, {'pmid': '22244176', 'type': 'RESULT', 'citation': "Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11."}, {'pmid': '22661464', 'type': 'RESULT', 'citation': 'Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.'}, {'pmid': '20881025', 'type': 'RESULT', 'citation': 'Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.'}, {'pmid': '34706764', 'type': 'DERIVED', 'citation': 'Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.'}, {'pmid': '25414187', 'type': 'DERIVED', 'citation': 'Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.'}, {'pmid': '24049718', 'type': 'DERIVED', 'citation': 'Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.'}, {'pmid': '24013578', 'type': 'DERIVED', 'citation': 'de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.'}, {'pmid': '23611993', 'type': 'DERIVED', 'citation': 'Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.'}, {'pmid': '23544203', 'type': 'DERIVED', 'citation': 'Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.'}, {'pmid': '23500412', 'type': 'DERIVED', 'citation': 'Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.'}, {'pmid': '22761263', 'type': 'DERIVED', 'citation': 'Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.'}, {'pmid': '22447863', 'type': 'DERIVED', 'citation': 'Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.'}]}, 'descriptionModule': {'briefSummary': 'Investigational Phase of the Study:\n\nThe objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.\n\nPost-Approval Phase of the Study:\n\nTo collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System', 'detailedDescription': 'During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes.\n* Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.\n* A history of former useful form vision in the worse-seeing eye.\n* Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old\n* Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site.\n* Must be willing and able to comply with the protocol testing and follow-up requirements.\n\nExclusion Criteria:\n\n* Optic Nerve disease\n\n * History of glaucoma\n * Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage\n* Diseases or conditions that effect retinal function including but not limited to:\n\n * Central retinal artery/vein occlusion (CRAO or CRVO)\n * End-stage diabetic retinopathy\n * Retinal detachment or history of retinal detachment\n * Trauma\n * Infectious or inflammatory retinal diseases\n* Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.\n* Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.\n* Diseases of the ocular surface including but not limited to keratitis sicca.\n* An ocular condition that predisposes the subject to eye rubbing.\n* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:\n\n * Cognitive decline including diagnosed forms of dementia and/or progressive neurological disease\n * Psychiatric Disease including diagnosed forms of depression\n * Does not speak a principal language associated with the region\n * Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.\n* Pregnancy\n* Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head\n* Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly.\n* Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study\n* Any health concern that makes general anesthesia inadvisable.\n* Subject has unrealistic expectations of the implant.\n* Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications.\n* Conditions likely to limit life to less than 1 year from the time of screening.\n* Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus)\n* Axial eye length \\<21.5 mm or \\>26.0 mm in the implanted eye as measured by ultrasound (US only)'}, 'identificationModule': {'nctId': 'NCT00407602', 'briefTitle': 'Argus® II Retinal Stimulation System Feasibility Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Second Sight Medical Products'}, 'officialTitle': 'Argus® II Retinal Stimulation System Feasibility Protocol', 'orgStudyIdInfo': {'id': 'CP-003-001'}, 'secondaryIdInfos': [{'id': 'National Eye Institute (NEI)', 'type': 'OTHER_GRANT', 'domain': '2R01EY012893-06A1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Implant of Argus II Retinal Prosthesis', 'description': 'This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.', 'interventionNames': ['Device: Implant of Argus II Retinal Prosthesis']}], 'interventions': [{'name': 'Implant of Argus II Retinal Prosthesis', 'type': 'DEVICE', 'description': 'epiretinal implantation of device', 'armGroupLabels': ['Implant of Argus II Retinal Prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Doheny Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins, Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania, Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Foundation of the Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Paris', 'country': 'France', 'facility': "Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51116', 'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Puerta de Hierro, Centro Medico, Centro de Retina', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': "Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205", 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'EC1V 2PD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Moorfields Eye Hospital, Vitreoretinal Research Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Anne-Marie Ripley', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Sight Medical Products'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Sight Medical Products', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}