Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-29 @ 6:29 PM
Study NCT ID:
NCT04208750
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Vision-R800 Device.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'meyerd@indiana.edu', 'phone': '812-855-0559', 'title': 'Dr. Dawn Meyer', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the COVID-19 pandemic this study was interrupted. Therefore, obtaining complete in-office data for some subjects was not possible. However, for all subjects possible at-home data was still obtained, as well as any in-office data that could be obtained remotely. Under allowed protocol deviation, some data was also collected in July following re-opening of the lab. We did rule out an effect of in-office as compared to remote data due to the COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': '5 weeks for each participant', 'eventGroups': [{'id': 'EG000', 'title': 'R-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'S-Refraction', 'description': 'Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Questionnaire Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R-Refraction Then S-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}, {'id': 'OG001', 'title': 'S-Refraction Then R-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}], 'classes': [{'title': 'Quickness', 'categories': [{'title': 'Prefer VR800', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Prefer Standard', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No Preference', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Efficiency', 'categories': [{'title': 'Prefer VR800', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Prefer Standard', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No Preference', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Comfort', 'categories': [{'title': 'Prefer VR800', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Prefer Standard', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No Preference', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Stress', 'categories': [{'title': 'Prefer VR800', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Prefer Standard', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'No Preference', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference between independent proportions', 'otherAnalysisDescription': 'For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Visit 5 (final visit), up to 5 weeks', 'description': 'Patient questions of refraction preference for quickness, efficiency, comfort, and stress', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'R-Refraction Then S-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}, {'id': 'FG001', 'title': 'S-Refraction Then R-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Visit 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'R-Refraction Then S-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}, {'id': 'BG001', 'title': 'S-Refraction Then R-Refraction', 'description': 'Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses\n\nStandard Phoropter: Refraction utilizing the standard phoropter with resulting glasses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.19', 'spread': '17.57', 'groupId': 'BG000'}, {'value': '38.28', 'spread': '18.81', 'groupId': 'BG001'}, {'value': '39.77', 'spread': '18.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Subject Classification', 'classes': [{'title': 'Count : Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Count : Presbyopes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'young adult = someone without presbyopia, does not require a near addition presbyope = someone with presbyopia, requires a near addition', 'unitOfMeasure': 'Participants'}, {'title': 'Subject Classification: Mean Age', 'classes': [{'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.89', 'spread': '7.27', 'groupId': 'BG000'}, {'value': '22.06', 'spread': '5.52', 'groupId': 'BG001'}, {'value': '22.88', 'spread': '6.38', 'groupId': 'BG002'}]}]}, {'title': 'Presbyopes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.26', 'spread': '6.07', 'groupId': 'BG000'}, {'value': '57.39', 'spread': '7.06', 'groupId': 'BG001'}, {'value': '56.80', 'spread': '6.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'young adult = someone without presbyopia, does not require a near addition presbyope = someone with presbyopia, requires a near addition', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-05', 'size': 397920, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-05T10:50', 'hasProtocol': True}, {'date': '2020-02-03', 'size': 196169, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-05T10:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2019-11-14', 'resultsFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-16', 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Questionnaire Response', 'timeFrame': 'at Visit 5 (final visit), up to 5 weeks', 'description': 'Patient questions of refraction preference for quickness, efficiency, comfort, and stress'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia', 'Astigmatism', 'Presbyopia']}, 'descriptionModule': {'briefSummary': 'Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current adaptated progressive addition lens wearer, if bifocal lens required\n* wearable pair of glasses \\< 2 years old\n* wear glasses at least 6 hours per day\n\nExclusion Criteria:\n\n* Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)\n* Formal training in optometry, vision science or in the eyecare field'}, 'identificationModule': {'nctId': 'NCT04208750', 'briefTitle': 'Clinical Investigation of the Vision-R800 Device.', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2', 'orgStudyIdInfo': {'id': 'Kollbaum003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R-Refraction', 'interventionNames': ['Device: Vision R-800 Phoropter', 'Device: Standard Phoropter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S-Refraction', 'interventionNames': ['Device: Vision R-800 Phoropter', 'Device: Standard Phoropter']}], 'interventions': [{'name': 'Vision R-800 Phoropter', 'type': 'DEVICE', 'description': 'Refraction utilizing the Vision R-800 Phoropter with resulting glasses', 'armGroupLabels': ['R-Refraction', 'S-Refraction']}, {'name': 'Standard Phoropter', 'type': 'DEVICE', 'description': 'Refraction utilizing the standard phoropter with resulting glasses', 'armGroupLabels': ['R-Refraction', 'S-Refraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Clinical Optics Research Lab', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pete Kollbaum, OD, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research', 'investigatorFullName': 'Pete Kollbaum, OD, PhD', 'investigatorAffiliation': 'Indiana University'}}}}