Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03708367
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Sponsor:
Organization:
Raw JSON
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Not all subjects completed all tests.'}, {'type': 'PRIMARY', 'title': 'Precision (Standard Deviation) of Preoperative Keratometric Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'classes': [{'title': 'Precision of Keratometry 1 (K1)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Precision of Keratometry 2 (K2)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks after first Pre-operative visit', 'description': 'Biometry testing was done pre-operatively', 'unitOfMeasure': 'diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.'}, {'type': 'PRIMARY', 'title': 'Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'classes': [{'title': 'Precision of Axial Length (AL)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Precision of Anterior Chamber Depth (ACD)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks after first Pre-operative visit', 'description': 'Biometry testing was done pre-operatively', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.'}, {'type': 'PRIMARY', 'title': 'Rate of Refractive Predictability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'classes': [{'title': '+/- 0.50 D', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}]}]}, {'title': '+/- 1.00 D', 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.', 'description': 'Percentage of eyes with achieved manifest refractive spherical equivalence (MRSE) within +/- 0.50 D and +/- 1.00 D.\n\nAchieved MRSE for each eye is defined as postoperative MRSE minus targeted MRSE.', 'unitOfMeasure': 'Percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.'}, {'type': 'PRIMARY', 'title': 'Rate of Bothersome Ocular Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'classes': [{'title': 'Q1a) Halos over the last 7 days', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Q2a) Starburst over the last 7 days', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Q3a) Multiple or Double vision over the last 7 days', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Q4a) Sensitivity to Light over the last 7 days', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Q5a) Glare related to scattered light over the last 7 days', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Q6a) Occlusions over the last 7 days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Q7a) Poor Low Light Vision over the last 7 days', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postoperative', 'description': 'Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Questionnaires were completed by bilaterally implanted participants.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.', 'description': 'Total Meibomian Gland Score: Fifteen Meibomian Glands (five temporally, centrally and nasally) in the lower eye are assessed on a scale of 0 - 3 (0 - No secretion, 1 - Inspissated (toothpaste consistency), 2 - Colored/cloudy liquid secretion or 3 - Clear liquid oil secretion). The sum of all 15 glands constitute the total meibomian gland secretion score (range 0-45).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '117', 'numSubjects': '59'}, {'groupId': 'FG001', 'numUnits': '115', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '116', 'numSubjects': '58'}, {'groupId': 'FG001', 'numUnits': '114', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': 'All study subjects enrolled from the normal surgical cataract population with bilateral mild to moderate Meibomian Gland Dysfunction, scheduled for bilateral cataract surgeries with Symfony Intraocular Lens implantation, at 5 sites in the U.S.A. 143 Subjects were consented, 26 screen-failed and 117 were randomized and bilaterally implanted. 115 evaluable subjects completed the study (58 in the study group and 57 in the Control Group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'LipiFlow treatment at Pre-operative'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'LipiFlow treatment following 3-month visit'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '30-39 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '>=70 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', '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', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (Including Indian)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'All eyes that are randomized and implanted'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-19', 'size': 3140737, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-08T10:47', 'hasProtocol': True}, {'date': '2018-11-16', 'size': 374936, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-08T10:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2018-10-08', 'resultsFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2018-10-12', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-01', 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)', 'timeFrame': '3 months Postoperative', 'description': 'Uncorrected Distance Visual Acuity was measured for the Study and Control groups at the 3-month visit using the Clinical Trial Suite (M\\&S Technologies) at 4.0 meters under photopic conditions (\\~85 cd/m2).'}, {'measure': 'Precision (Standard Deviation) of Preoperative Keratometric Measurements', 'timeFrame': '2-4 weeks after first Pre-operative visit', 'description': 'Biometry testing was done pre-operatively'}, {'measure': 'Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)', 'timeFrame': '2-4 weeks after first Pre-operative visit', 'description': 'Biometry testing was done pre-operatively'}, {'measure': 'Rate of Refractive Predictability', 'timeFrame': 'Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.', 'description': 'Percentage of eyes with achieved manifest refractive spherical equivalence (MRSE) within +/- 0.50 D and +/- 1.00 D.\n\nAchieved MRSE for each eye is defined as postoperative MRSE minus targeted MRSE.'}, {'measure': 'Rate of Bothersome Ocular Symptoms', 'timeFrame': '3 months postoperative', 'description': 'Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative'}, {'measure': 'Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative', 'timeFrame': 'Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.', 'description': 'Total Meibomian Gland Score: Fifteen Meibomian Glands (five temporally, centrally and nasally) in the lower eye are assessed on a scale of 0 - 3 (0 - No secretion, 1 - Inspissated (toothpaste consistency), 2 - Colored/cloudy liquid secretion or 3 - Clear liquid oil secretion). The sum of all 15 glands constitute the total meibomian gland secretion score (range 0-45).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataracts', 'Meibomian Gland Dysfunction (MGD)']}, 'referencesModule': {'references': [{'pmid': '37318707', 'type': 'DERIVED', 'citation': 'Matossian C, Chang DH, Whitman J, Clinch TE, Hu J, Ji L, Murakami D, Wang Y, Blackie CA. Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation. Ophthalmol Ther. 2023 Oct;12(5):2427-2439. doi: 10.1007/s40123-023-00740-x. Epub 2023 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all criteria apply to each study eye):\n\n* Minimum 22 years of age.\n* Bilateral cataracts for which phacoemulsification extraction and implantation with Symfony IOLs have been planned.\n* Evidence of Meibomian Gland Dysfunction (MGD) in both eyes based on assessment of meibomian glands of the lower eyelid\n* None to moderate dry eye symptoms with questionnaire\n* Clear intraocular media other than cataract in each eye.\n* Availability, willingness, ability and sufficient cognitive awareness to comply with the study protocol including: randomization; examination procedures; completion of planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye treatments.\n* Ability to understand, read and write English to consent to study participation and complete study questionnaires.\n* Willingness to sign informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing country.\n\nExclusion Criteria (all criteria apply to each study eye):\n\n* Any medical finding that would predictably result in a postoperative best corrected distance visual acuity worse than 20/30 in either eye.\n* Use of systemic or ocular medications that, in the opinion of the investigator, may affect vision or impact pupil dilation or iris structure.\n* Irregular corneal astigmatism.\n* Any clinically-significant corneal pathology / abnormality other than regular corneal astigmatism.\n* Any clinically-significant pupil abnormalities.\n* Subjects with conditions associated with increased risk of zonular rupture.\n* Unwillingness or inability to stop wearing contact lens at least two weeks prior to the baseline visit.\n* Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the study.\n* Systemic disease condition that causes dry eye.\n* Unwillingness or inability to abstain from the use of systemic medications known to cause dryness for the study duration. Subjects must have discontinued these medications for at least 1 month prior to Preoperative Visit.\n* Unwillingness or inability to abstain from the use of systemic antihistamines.\n* Unwillingness or inability to abstain from use of prescription medications for treatment of MGD or dry eye. Subject must have dicontinued using prescription medications for MGD or dry eye at least 1 month prior to baseline preoperative visit #1 measurements.\n* Any of the following ocular (eye or eyelid) conditions in either eye within 3 months prior to the LipiFlow treatment visit:\n\n * Prior intraocular, oculoplastic, corneal or refractive surgery procedure (LASIK, LASEK, RK, PRK, etc.).\n * Ocular trauma.\n * Ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.\n * History of recurrent ocular inflammation.\n * Punctal plug insertion or punctal occlusion.\n* Any of the following active ocular (eye or eyelid) conditions in either eye at the baseline Preoperative Visit #1 measurements:\n\n * Ocular infection.\n * Ocular inflammation.\n * Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis\n * Severe (Grade 3 or 4) inflammation of the eyelid.\n * Eyelid abnormalities that affect lid function.\n * Ocular surface abnormality that may compromise corneal integrity.\n* Concurrent participation or participation within 30 days prior to study visit in any other clinical trial.\n* Planned monovision correction.\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.'}, 'identificationModule': {'nctId': 'NCT03708367', 'briefTitle': 'A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Surgical Vision, Inc.'}, 'officialTitle': 'A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice', 'orgStudyIdInfo': {'id': 'DRYE-102-SELF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group: LipiFlow Treatment at PreOp', 'description': 'Study subjects that meet all inclusion and exclusion criteria will be randomized to receive LipiFlow Thermal Pulsation System treatment at preoperative visit before bilateral implantation with commercially-available Symfony Intraocular Lens', 'interventionNames': ['Device: LipiFlow Thermal Pulsation System']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Study subjects that meet all inclusion and exclusion criteria will be randomized to not receive the LipiFlow Thermal Pulsation System treatment at a preoperative visit before bilaterally implanted with the commercially available Symfony Intraocular Lens. Control Group will receive LipiFlow treatment as cross-over group at 3 months postoperative visit.', 'interventionNames': ['Device: LipiFlow Thermal Pulsation System']}], 'interventions': [{'name': 'LipiFlow Thermal Pulsation System', 'type': 'DEVICE', 'description': 'Treatment at preoperative visit for study group', 'armGroupLabels': ['Study Group: LipiFlow Treatment at PreOp']}, {'name': 'LipiFlow Thermal Pulsation System', 'type': 'DEVICE', 'description': 'Treatment at 3 month visit as the cross-over group', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye & Laser Center, Inc.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Eye Doctors of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '08534', 'city': 'Pennington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Matossian Eye Associates', 'geoPoint': {'lat': 40.32844, 'lon': -74.79072}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'JW Eye Associates, P.A.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Eye & Laser Center, P.A.', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}], 'overallOfficials': [{'name': 'Priya Janakiraman, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Surgical Vision, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Surgical Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}