Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03444961
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
Sponsor:
Organization:
Raw JSON
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Participants were asked to complete two trials was recorded, with a maximum time of 60 seconds per trial.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects of CAREN Virtual Reality System on Square Localization Visual Function Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}, {'id': 'OG001', 'title': 'Post-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '274.62', 'groupId': 'OG000', 'lowerLimit': '104.12', 'upperLimit': '463.47'}, {'value': '245.43', 'groupId': 'OG001', 'lowerLimit': '104.12', 'upperLimit': '463.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 wks', 'description': 'The square localization test presents a 2.75" square (250 pixels) at a random location on a black background and the patient is instructed to try to touch the square. The test measures the patient\'s ability to locate an object and results are calculated as a mean error (how far away in pixels from the square the patient touches the screen). A lower mean error (the distance from the square) indicates better patient performance.', 'unitOfMeasure': 'pixels', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}, {'id': 'OG001', 'title': 'Post-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.68', 'groupId': 'OG000', 'lowerLimit': '14.51', 'upperLimit': '95.16'}, {'value': '58.12', 'groupId': 'OG001', 'lowerLimit': '14.51', 'upperLimit': '95.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 wks', 'description': "The direction of motion test assesses the patient's ability to determine the direction an object is moving. The patient is presented with a white line (1.4'' wide) that moves across the screen in a random series of directions and angles. Patients are instructed to trace their finger on the monitor in the direction they perceived the line moved. Results are calculated as a mean error (how far off, in degrees, was the patient from the direction of the moving line). The higher the mean error/score, the worse the outcome.", 'unitOfMeasure': 'degrees', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 wks', 'description': "The grating visual acuity test measures the patient's visual acuity using the principles of acuity charts modified for ultra-low vision subjects. The patients are presented with black and white bars in one of four orientations (horizontal, vertical, diagonal to the left or diagonal to the right). The bars are present on the screen for 5 seconds during which the patient may scan the screen and then provide a verbal response as to which orientation they perceived the bars. The widths of the bars are varied to evaluate different levels of visual acuity. A lower score is associated with better outcomes with 2.9 being the worst possible score.", 'unitOfMeasure': 'logMAR', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects of CAREN Virtual Reality System on Gait Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}, {'id': 'OG001', 'title': 'Post-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '111.05', 'groupId': 'OG000', 'lowerLimit': '72.84', 'upperLimit': '159.70'}, {'value': '130.7', 'groupId': 'OG001', 'lowerLimit': '72.84', 'upperLimit': '159.70'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 wks', 'description': "Subject's gait assessed by meters traveled while localizing objects on the CAREN system. The higher scores are associated with better outcomes (further distance walked).", 'unitOfMeasure': 'meters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}, {'id': 'OG001', 'title': 'Post-CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.125', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '34.375', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 wks', 'description': 'The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual\'s confidence in performing activities without losing balance. It is a 0% to 100% continuous response scale with 0 representing "no confidence" and 100 representing "complete confidence."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAREN System Training', 'description': 'CAREN training\n\nCAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-01', 'size': 461129, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-23T14:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2017-10-26', 'resultsFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2018-02-19', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-24', 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire', 'timeFrame': '6 wks', 'description': 'The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual\'s confidence in performing activities without losing balance. It is a 0% to 100% continuous response scale with 0 representing "no confidence" and 100 representing "complete confidence."'}], 'primaryOutcomes': [{'measure': 'Effects of CAREN Virtual Reality System on Obstacle Course Navigation', 'timeFrame': '6 wks', 'description': 'Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)'}, {'measure': 'Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training', 'timeFrame': '6 wks', 'description': 'Timed Up and Go testing - functional mobility test that requires the individual to stand from a chair, ambulate three meters to a target, turn around, return to the chair, and sit down. Participants were asked to complete two trials was recorded, with a maximum time of 60 seconds per trial.'}, {'measure': 'Effects of CAREN Virtual Reality System on Square Localization Visual Function Test', 'timeFrame': '6 wks', 'description': 'The square localization test presents a 2.75" square (250 pixels) at a random location on a black background and the patient is instructed to try to touch the square. The test measures the patient\'s ability to locate an object and results are calculated as a mean error (how far away in pixels from the square the patient touches the screen). A lower mean error (the distance from the square) indicates better patient performance.'}, {'measure': 'Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.', 'timeFrame': '6 wks', 'description': "The direction of motion test assesses the patient's ability to determine the direction an object is moving. The patient is presented with a white line (1.4'' wide) that moves across the screen in a random series of directions and angles. Patients are instructed to trace their finger on the monitor in the direction they perceived the line moved. Results are calculated as a mean error (how far off, in degrees, was the patient from the direction of the moving line). The higher the mean error/score, the worse the outcome."}, {'measure': 'Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test', 'timeFrame': '6 wks', 'description': "The grating visual acuity test measures the patient's visual acuity using the principles of acuity charts modified for ultra-low vision subjects. The patients are presented with black and white bars in one of four orientations (horizontal, vertical, diagonal to the left or diagonal to the right). The bars are present on the screen for 5 seconds during which the patient may scan the screen and then provide a verbal response as to which orientation they perceived the bars. The widths of the bars are varied to evaluate different levels of visual acuity. A lower score is associated with better outcomes with 2.9 being the worst possible score."}, {'measure': 'Effects of CAREN Virtual Reality System on Gait Assessment', 'timeFrame': '6 wks', 'description': "Subject's gait assessed by meters traveled while localizing objects on the CAREN system. The higher scores are associated with better outcomes (further distance walked)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Argus II Retinal Prosthesis System', 'Rehabilitation'], 'conditions': ['Retinitis Pigmentosa']}, 'referencesModule': {'references': [{'pmid': '31937474', 'type': 'DERIVED', 'citation': 'Rachitskaya A, Yuan A, Davidson S, Streicher M, DeBenedictis M, Rosenfeldt AB, Alberts J. Computer-Assisted Immersive Visual Rehabilitation in Argus II Retinal Prosthesis Recipients. Ophthalmol Retina. 2020 Jun;4(6):613-619. doi: 10.1016/j.oret.2019.11.007. Epub 2019 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the current project is to fill the unmet clinical needs around the objective assessment of visual function and develop outcome-oriented visual rehabilitation approach using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of the Argus II Retinal Prosthesis System\n* Ability to provide informed consent\n* Ability to follow two-step commands\n* Ability to ambulate 300+ feet with or without visual assistance\n* Able to tolerate Argus device turned on for \\>20 continuous minutes.\n\nExclusion Criteria:\n\n* Dementia\n* Musculoskeletal contraindication to exercise or walking\n* Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).'}, 'identificationModule': {'nctId': 'NCT03444961', 'briefTitle': 'Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery', 'orgStudyIdInfo': {'id': '17-1355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAREN system training', 'description': 'CAREN training', 'interventionNames': ['Device: CAREN system training']}], 'interventions': [{'name': 'CAREN system training', 'type': 'DEVICE', 'description': 'CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.', 'armGroupLabels': ['CAREN system training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Aleksandra Rachitskaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine', 'investigatorFullName': 'Aleksandra Rachitskaya, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}