Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT03579433
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postmarket Study of an Intraocular Lens Power Selection System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. CDMA Project Lead, Surgical', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days.', 'description': 'Adverse events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular adverse events is included with unit of "eyes."', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye)', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ORA With VerifEye+ Study Eye', 'description': 'All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 10, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Barrett Toric Calculator Study Eye', 'description': 'All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 7, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Overall Systemic', 'description': 'All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Posterior capsule opacification', 'notes': 'Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Intraocular pressure increased', 'notes': 'Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Metamorphopsia', 'notes': 'Assessed as not related to the Barrett Toric Calculator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Retinal detachment', 'notes': 'Assessed as not related to the ORA With VerifEye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Retinal tear', 'notes': 'Assessed as not related to the ORA With VerifEye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Eye laser surgery', 'notes': 'Assessed as not related to the ORA With VerifEye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Intraocular lens implant', 'notes': 'Assessed as not related to the Barrett Toric Calculator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Intraocular lens repositioning', 'notes': 'Assessed as not related to the Barrett Toric Calculator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ORA With VerifEye+', 'description': 'Acrysof® IQ Toric IOL and ORA with VerifEye+'}, {'id': 'OG001', 'title': 'Barrett Toric Calculator', 'description': 'Acrysof® IQ Toric IOL and Barrett Toric Calculator'}], 'classes': [{'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000'}, {'value': '87.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'The Per Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and recommended by ORA and with no major protocol deviations and data at visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'First surgical eye randomly assigned to Acrysof® IQ Toric IOL and Optiwave Refractive Analysis with VerifEye+ (ORA With VerifEye+) or Acrysof® IQ Toric IOL and Barrett Toric Calculator (Barrett Toric Calculator), with the second surgical eye (fellow eye) assigned to the alternative group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'ORA With VerifEye+', 'comment': 'Successful implantation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'Barrett Calculator', 'comment': 'Successful implantation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Of the 124 subjects enrolled, 12 subjects were discontinued prior to randomization, and 8 subjects were randomized, but not treated in either eye. This reporting group includes all subjects with attempted implantation of an intraocular lens (IOL) in one or both eyes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'First surgical eye randomly assigned to Acrysof® IQ Toric (IOL) and Optiwave Refractive Analysis (ORA) with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '8.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than 65 years old', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': '65 years old or older', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '96', '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': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-20', 'size': 1861880, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-19T10:20', 'hasProtocol': True}, {'date': '2019-03-22', 'size': 885626, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-19T10:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2018-06-26', 'resultsFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-03', 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6', 'timeFrame': 'Month 6', 'description': 'Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IOL', 'Intraocular lens', 'Astigmatism', 'Cataract Surgery'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.', 'detailedDescription': 'Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned cataract surgery with IOL implantation\n* Able to comprehend and sign the informed consent form\n* Preoperative astigmatism of 0.75 to 3.00 Diopter\n* Willing and able to complete all required postoperative visits\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Unclear intraocular media other than cataract\n* Pregnant or lactating\n* Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03579433', 'briefTitle': 'Postmarket Study of an Intraocular Lens Power Selection System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric', 'orgStudyIdInfo': {'id': 'ILX369-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORA with VerifEye+', 'description': 'First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.', 'interventionNames': ['Device: ORA with VerifEye+', 'Device: Acrysof® IQ Toric IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Barrett Toric Calculator', 'description': 'First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.', 'interventionNames': ['Other: Alcon Barrett Toric Calculator', 'Device: Acrysof® IQ Toric IOL']}], 'interventions': [{'name': 'ORA with VerifEye+', 'type': 'DEVICE', 'description': 'Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.', 'armGroupLabels': ['ORA with VerifEye+']}, {'name': 'Alcon Barrett Toric Calculator', 'type': 'OTHER', 'description': 'Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.', 'armGroupLabels': ['Barrett Toric Calculator']}, {'name': 'Acrysof® IQ Toric IOL', 'type': 'DEVICE', 'description': 'Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)', 'armGroupLabels': ['Barrett Toric Calculator', 'ORA with VerifEye+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32757', 'city': 'Mt. Dora', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.80249, 'lon': -81.64452}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '12603', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75965', 'city': 'Nacogdoches', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 31.60351, 'lon': -94.65549}}], 'overallOfficials': [{'name': 'Clinical Operations Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}