Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
Study NCT ID:
NCT02526693
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2015-08-06
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D011681', 'term': 'Pupil Disorders'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gspaeth@willseye.org', 'phone': '215-928-3123', 'title': 'George L. Spaeth, MD', 'organization': 'Wills Eye Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size. Single site design. Single light design limits pupil stimulus.'}}, 'adverseEventsModule': {'timeFrame': '1 examination, one hour', 'eventGroups': [{'id': 'EG000', 'title': 'Glaucoma Patients', 'description': '50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service were tested with RAPDx Pupillometer.\n\nKonan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls', 'description': '50 Healthy controls recruited from Wills Eye Hospital Glaucoma Service staff, family and friends were tested with RAPDx Pupillometer.\n\nKonan (Konan Medical USA, Irvine, CA) RAPDx (relative afferent pupillary defect) test utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amplitude Asymmetry of Pupil Constriction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glaucoma Patients', 'description': 'Glaucoma patients recruited from Glaucoma Service at Wills Eye Hospital will be tested with RAPDx Pupillography machine\n\nRelative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy subjects are recruited from the Wills Eye clinic, who will be tested with the RAPDx Pupillography machine\n\nRelative afferent pupillary defect RAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared with eye-tracking and automated blink detection to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}], 'classes': [{'title': 'Custom sequence', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Standard sequence', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 examination, one hour', 'description': "Pupil size changes when light shines into the eyes making the diameter of the pupil smaller (constriction). The size of the pupil's reaction to light, measured in millimeters, is the amplitude or change in diameter. Amplitude of maximum pupil constriction (pupil size) when light is shone is compared between the right and left eyes. Asymmetry is the difference between maximum pupil size of the two eyes.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Latency Asymmetry of Pupil Constriction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glaucoma', 'description': '50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer.\n\nRAPDx Pupillometer: The Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': '50 Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer.\n\nPupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}], 'classes': [{'title': 'Custom sequence', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Standard sequence', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 examination, one hour', 'description': "Pupil size changes at different speeds when light shines into the eyes making the diameter of the pupil smaller (constriction). The speed of the pupil's reaction to light is the latency or amount of time. Latency of maximum pupil constriction when light is shone is compared between the right and left eyes. Asymmetry is the difference in time it takes for maximum pupil constriction between the two eyes.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Constriction Asymmetry Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glaucoma Patients', 'description': '50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with relative afferent pupillary defect (RAPDx) Pupillometer.\n\nPupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': '50 Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with relative afferent pupillary defect (RAPDx) Pupillometer.\n\nPupillometer: The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light and dark with a standard testing sequence and a custom sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 examination, one hour', 'description': 'Log difference between duration of maximum pupil constriction when light is shone into the right versus the left eye. The duration of maximum constriction is calculated as time in milliseconds between point of maximum constriction and time when pupil amplitude has reached 50% of peak amplitude of dilation.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glaucoma Patients', 'description': '50 Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with RAPDx Pupillometer machine.\n\nRAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.'}, {'id': 'FG001', 'title': 'Healthy Controls', 'description': '50 Healthy subjects with no eye diseases from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with RAPDx Pupillometer machine.\n\nRAPDx Pupillometer: Konan relative afferent pupillary defect RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glaucoma', 'description': 'Glaucoma patients are recruited from Wills Eye Hospital glaucoma service, who will be tested with the RAPDx Pupillography machine.\n\nRAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.'}, {'id': 'BG001', 'title': 'Healthy Control', 'description': 'Healthy subjects are recruited from Wills Eye Hospital primary care service, who will be tested with the RAPDx Pupillography machine.\n\nRAPDx Pupillography: The Konan RAPDx (Konan Medical USA, Irvine, CA) utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '37', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', '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', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Glaucoma patients were recruited from Wills Eye Hospital Glaucoma Service, Philadelphia, PA, USA. Healthy controls were recruited from staff, friends and family members of Wills Eye Hospital Glaucoma Research Center.', 'unitOfMeasure': 'participants'}], 'populationDescription': '4 participants enrolled were excluded from analysis due to other comorbidities or abnormal values of measurement parameters. Three excluded participants were from the Glaucoma Group, one was from the Control Group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2015-08-06', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-21', 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude Asymmetry of Pupil Constriction', 'timeFrame': '1 examination, one hour', 'description': "Pupil size changes when light shines into the eyes making the diameter of the pupil smaller (constriction). The size of the pupil's reaction to light, measured in millimeters, is the amplitude or change in diameter. Amplitude of maximum pupil constriction (pupil size) when light is shone is compared between the right and left eyes. Asymmetry is the difference between maximum pupil size of the two eyes."}, {'measure': 'Latency Asymmetry of Pupil Constriction', 'timeFrame': '1 examination, one hour', 'description': "Pupil size changes at different speeds when light shines into the eyes making the diameter of the pupil smaller (constriction). The speed of the pupil's reaction to light is the latency or amount of time. Latency of maximum pupil constriction when light is shone is compared between the right and left eyes. Asymmetry is the difference in time it takes for maximum pupil constriction between the two eyes."}, {'measure': 'Maximum Constriction Asymmetry Duration', 'timeFrame': '1 examination, one hour', 'description': 'Log difference between duration of maximum pupil constriction when light is shone into the right versus the left eye. The duration of maximum constriction is calculated as time in milliseconds between point of maximum constriction and time when pupil amplitude has reached 50% of peak amplitude of dilation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'relative afferent pupillary defect', 'pupillography'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The Konan RAPDx (Konan Medical USA, Irvine, CA) is a newly patented pupillography device.The aims of this study are to assess the ability of the RAPDx to distinguish between healthy subjects and patients with confirmed glaucoma using standard testing sequences developed for use at the Wills Eye Hospital Glaucoma Research Center and to determine the combination of demographic, clinical, and RAPDx testing parameters which allow for maximum sensitivity and specificity.', 'detailedDescription': 'The RAPDx utilizes noninvasive digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify the pupillary response to light.\n\nDuring the scheduled appointment, all patients will receive an undilated fundus examination by the attending ophthalmologist. The following data will be collected; Demographic information, Visual acuity, Intraocular pressure (IOP) measured by Goldmann applanation tonometry, Disc damage likelihood scale (DDLS), Vertical cup/disc ratio, Gonioscopy (if not documented in the chart within the past 2 years) and Humphrey visual field examination.\n\nEach participant will undergo RAPDx testing with two different testing sequences. They are separated by a 10-second resting period during which the patient is instructed to close his or her eyes. The exam may be paused at any time and re-alignment may be performed during any pause. The two testing sequences are:\n\n1. Standard Factory Setting: 0.1-second stimuli with 2-second inter-stimuli pauses;\n2. Custom Setting: 3-second stimuli with 1-second inter-stimuli pauses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGlaucoma patients:\n\n* optic nerve damage (neuroretinal rim notch, asymmetric inter-eye cup to disc (c/d\\_ ratio \\>0.2 or disc damage likelihood scale (DDLS) \\>2, or absence of neuroretinal rim not due to other cause)\n* glaucomatous visual field (VF) deficits (cluster of 3 or more points on pattern deviation plot depressed below 5% level, at least 1 depressed below 1% level; OR corrected pattern standard deviation/pattern standard deviation significant at P \\<0.05; or glaucoma hemifield test "outside normal limits") with good reliability indices (fixation losses, false-positive rate, false-negative rate each \\< 33%).\n\nHealthy subjects:\n\n* normal optic nerve exam\n* normal reliable VF (Humphrey mean deviation (MD) \\>-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each \\< 33%)\n* open angles gonioscopy.\n\nExclusion Criteria:\n\n* Abnormal ocular motility preventing binocular fixation (e.g. strabismus, nystagmus).\n* Any condition preventing adequate visualization and examination of pupil or optic nerve (e.g. dense corneal opacities or lens opacities).\n* Active infection of anterior or posterior segments of the eye.\n* Any intraocular surgical or laser procedure within previous 4 weeks.\n* Any non-glaucomatous condition causing RAPD, anisocoria or corectopia (ex. optic neuropathy, Horner\'s syndrome, previous iris injury due to trauma or surgery, etc.).\n* Subjects under age 18 or subjects presently housed in correctional facility.'}, 'identificationModule': {'nctId': 'NCT02526693', 'briefTitle': 'Is the RAPDx Pupillograph Able to Distinguish Between Glaucoma Subjects and Healthy Subjects?', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'RAPDx Pupillography for Early Detection of Glaucoma', 'orgStudyIdInfo': {'id': '14-400E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Glaucoma Patients', 'description': 'Glaucoma patients recruited from Wills Eye Hospital Glaucoma Service will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.', 'interventionNames': ['Diagnostic Test: Pupillometer']}, {'type': 'OTHER', 'label': 'Healthy Controls', 'description': 'Healthy subjects with no eye diseases recruited from Wills Eye Hospital Glaucoma Service staff, family and friends will be tested with the relative afferent pupillary defect test (RAPDx) Pupillometer. The noninvasive RAPDx measures the pupils response during light stimulation.', 'interventionNames': ['Diagnostic Test: Pupillometer']}], 'interventions': [{'name': 'Pupillometer', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Relative afferent pupillary defect pupillometer'], 'description': 'The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.', 'armGroupLabels': ['Glaucoma Patients', 'Healthy Controls']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'George Spaeth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Manuscript is has not been finalized.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'George L. Spaeth MD', 'investigatorAffiliation': 'Wills Eye'}}}}