Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-01 @ 9:30 PM
Study NCT ID:
NCT03219567
Status:
TERMINATED
Last Update Posted:
2022-04-04
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anthony.kuo@duke.edu', 'phone': '919-684-3799', 'title': 'Anthony Kuo, M.D.', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Normals', 'description': 'Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients With a History of Cataract Surgery or High Myopia', 'description': 'Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.\n\nMagnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normals', 'description': 'Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.'}, {'id': 'OG001', 'title': 'Patients With Previous LASIK Who Will be Undergoing Cataract Surgery', 'description': 'Patients with previous LASIK who will be undergoing cataract surgery subjects will be imaged with the OCT system.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.'}, {'id': 'OG002', 'title': 'Patients With a History of Cataract Surgery or High Myopia', 'description': 'Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.\n\nMagnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG002'], 'groupDescription': 'OCT compared to MRI', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '36 months', 'description': 'The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Participants who were imaged with both the OCT system and MRI ("Patients with a history of cataract surgery or high myopia" group only). Data not collected on 40 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normals', 'description': 'Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.'}, {'id': 'FG001', 'title': 'Patients With a History of Cataract Surgery or High Myopia', 'description': 'Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.\n\nMagnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normals', 'description': 'Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.'}, {'id': 'BG001', 'title': 'Patients With a History of Cataract Surgery or High Myopia', 'description': 'Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.\n\nOptical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.\n\nMagnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', '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': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-14', 'size': 990110, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T13:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2020-11-16', 'completionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2017-07-13', 'dispFirstSubmitQcDate': '2020-11-20', 'resultsFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2017-07-13', 'dispFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-11', 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI', 'timeFrame': '36 months', 'description': 'The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'conditions': ['Image, Body']}, 'descriptionModule': {'briefSummary': 'The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT).\n\nThe research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison.\n\nThere are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years or older.\n* Pseudophakic group: has had prior uncomplicated cataract surgery with a monofocal or toric intraocular lens, able to undergo head MRI\n* High myopia group: refraction equal to or stronger than -6 D spherical equivalent, able to undergo head MRI\n\nExclusion Criteria:\n\n* under 21 years of age, unable or unwilling to give consent.\n* Pseudophakic group: complications with cataract surgery or insertion of a multifocal intraocular lens, failure to pass MRI pre-screening (e.g. prior metallic implants, claustrophobic), unable to fixate.\n* High myopia group: failure to pass MRI pre-screening, unable to fixate.'}, 'identificationModule': {'nctId': 'NCT03219567', 'briefTitle': 'Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care', 'orgStudyIdInfo': {'id': 'Pro00056946'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normals', 'description': 'Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.', 'interventionNames': ['Device: Optical Coherence Tomography (OCT)']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with a history of cataract surgery or high myopia', 'description': 'Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.', 'interventionNames': ['Device: Optical Coherence Tomography (OCT)', 'Device: Magnetic resonance imaging (MRI)']}], 'interventions': [{'name': 'Optical Coherence Tomography (OCT)', 'type': 'DEVICE', 'description': 'Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.\n\nThe study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.', 'armGroupLabels': ['Normals', 'Patients with a history of cataract surgery or high myopia']}, {'name': 'Magnetic resonance imaging (MRI)', 'type': 'DEVICE', 'description': 'Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.', 'armGroupLabels': ['Patients with a history of cataract surgery or high myopia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}