Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-30 @ 8:00 AM
Study NCT ID:
NCT01714635
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of Expanded Designs of a Multifocal IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kendra.hileman@amo.abbott.com', 'phone': '714-247-8613', 'title': 'Kendra Hileman, Ph.D., Director, Clinical Research & Development', 'organization': 'Abbott Medical Optics'}, 'certainAgreement': {'otherDetails': 'After the trial is completed, investigators must obtain approval from AMO in writing prior to disclosing trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens', 'otherNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Secondary surgical intervention - not lens-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary surgical intervention - lens-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orbital fracture', 'notes': 'Orbital fracture was attributed to a fall. Subject also sustained limbal wound rupture and iris prolapse.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Central retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endophthalmitis/hypopyon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid macular edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.253', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.179', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '0.582', 'spread': '0.014', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'six months', 'description': 'Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative', 'unitOfMeasure': 'LogMAR VA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Mean Diopter Range With VA of 20/40 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'six months', 'description': 'Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\\*) to reach the 6-month visit were included in the substudy.\n\n\\* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Spectacle Independence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'OG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'six months', 'description': 'Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Five subjects (3 from Group #1 \\[145-142\\], 1 from Group #2 \\[150-149\\], and 1 from the monofocal control group \\[146-145\\]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'FG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'FG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Missed 6-month exam', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '445', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tecnis Multifocal Intraocular Lens #1', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'BG001', 'title': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens\n\nTecnis Multifocal Intraocular Lens'}, {'id': 'BG002', 'title': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)\n\nMonofocal Intraocular Lens'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 60 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': '60 - 69 years', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': '70 - 79 years', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to 80 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Age was grouped by catagories as described in the table.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '443', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2012-10-24', 'resultsFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-09', 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm', 'timeFrame': 'six months', 'description': 'Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative'}], 'secondaryOutcomes': [{'measure': 'Mean Diopter Range With VA of 20/40 or Better', 'timeFrame': 'six months', 'description': 'Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\\*) to reach the 6-month visit were included in the substudy.\n\n\\* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.'}, {'measure': 'Spectacle Independence', 'timeFrame': 'six months', 'description': 'Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract', 'IOL', 'intraocular lens'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 18 years of age\n* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes\n* Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source\n* Potential for postoperative best-corrected visual acuity of 20/25 or better\n* Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism\n* Clear intraocular media, other than cataract\n* Availability, willingness and sufficient cognitive awareness to comply with examination procedures\n* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries\n* Ability to understand and respond to a questionnaire verbally administered in English\n\nExclusion Criteria:\n\n* Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D\n* Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)\n* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes\n* Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery\n* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study\n* Inability to achieve keratometric stability for contact lens wearers\n* Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study\n* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects\n* Use of systemic or ocular medications that may affect vision\n* Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery\n* Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)\n* Poorly-controlled diabetes\n* Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.\n* Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)\n* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes\n* Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial\n* Desire for monovision correction'}, 'identificationModule': {'nctId': 'NCT01714635', 'briefTitle': 'Clinical Investigation of Expanded Designs of a Multifocal IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL', 'orgStudyIdInfo': {'id': 'DIOL-106-ZMLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tecnis Multifocal Intraocular lens #1', 'description': 'A low diopter add multifocal intraocular lens', 'interventionNames': ['Device: Tecnis Multifocal Intraocular Lens']}, {'type': 'EXPERIMENTAL', 'label': 'Tecnis Multifocal Intraocular Lens #2', 'description': 'A low diopter add multifocal intraocular lens', 'interventionNames': ['Device: Tecnis Multifocal Intraocular Lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monofocal Intraocular Lens', 'description': 'Commercially available monofocal intraocular lens (IOL)', 'interventionNames': ['Device: Monofocal Intraocular Lens']}], 'interventions': [{'name': 'Tecnis Multifocal Intraocular Lens', 'type': 'DEVICE', 'armGroupLabels': ['Tecnis Multifocal Intraocular Lens #2', 'Tecnis Multifocal Intraocular lens #1']}, {'name': 'Monofocal Intraocular Lens', 'type': 'DEVICE', 'armGroupLabels': ['Monofocal Intraocular Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fishkind, Bakewell & Maltzman Eye Care & Surgery Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72757', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Boozman-Hof Regional Eye Clinic', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye & Laser Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Assil Eye Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Cape Coral Eye Center (Argus Research Center)', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Virdi Eye Clinic & Laser Vision Center', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eye Surgeons of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '71303', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Wallace Eye Surgery', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pepose Vision Institute', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'zip': '17810', 'city': 'Allenwood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Eye Center of Central PA', 'geoPoint': {'lat': 41.10758, 'lon': -76.8983}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '18702', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bucci Cataract & Laser Vision', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Loden Vision Center', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Whitsett Vision Group', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Lone Star Eye Care', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '98503', 'city': 'Lacey', 'state': 'Washington', 'country': 'United States', 'facility': 'Clarus Eye Centre', 'geoPoint': {'lat': 47.03426, 'lon': -122.82319}}, {'zip': 'B91 2AW', 'city': 'Solihull', 'country': 'United Kingdom', 'facility': 'The Midline Eye Institute', 'geoPoint': {'lat': 52.41426, 'lon': -1.78094}}], 'overallOfficials': [{'name': 'Kendra Hileman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Optics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}