Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-25 @ 4:14 PM
Study NCT ID:
NCT02987660
Status:
TERMINATED
Last Update Posted:
2019-01-14
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. Global Brand Medical Affairs Lead, CDMA Surgical', 'organization': 'Alcon, A Novartis Division'}, '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': 'Surgery through study completion, an average of 3 months, per the early termination criteria.', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'LASIK', 'description': 'Subjects exposed to topography guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SMILE', 'description': 'Subjects exposed to SMILE with VisuMax laser in bilateral surgery', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LASIK', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery'}, {'id': 'OG001', 'title': 'SMILE', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.', 'unitOfMeasure': 'percentage of eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'ITT with non-missing data'}, {'type': 'SECONDARY', 'title': 'Mean Manifest Refraction Cylinder at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LASIK', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery'}, {'id': 'OG001', 'title': 'SMILE', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.575', 'spread': '0.4091', 'groupId': 'OG000'}, {'value': '-0.232', 'spread': '0.1539', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'ITT with non-missing data'}, {'type': 'SECONDARY', 'title': 'Mean Uncorrected Visual Acuity (UCVA) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LASIK', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery'}, {'id': 'OG001', 'title': 'SMILE', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.100', 'spread': '0.1360', 'groupId': 'OG000'}, {'value': '-0.164', 'spread': '0.0769', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'ITT with non-missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LASIK', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery'}, {'id': 'FG001', 'title': 'SMILE', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 1 study center located in France.', 'preAssignmentDetails': 'Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LASIK', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery'}, {'id': 'BG001', 'title': 'SMILE', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all eyes of randomized subjects for whom the treatment was initiated (Intent to treat Analysis Set) (ITT).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-19', 'size': 5164351, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-09T18:43', 'hasProtocol': True}, {'date': '2016-12-19', 'size': 2478165, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-09T18:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'management decision; non patient safety related reason', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2016-12-07', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-09', 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months', 'timeFrame': 'Month 3', 'description': 'Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.'}], 'secondaryOutcomes': [{'measure': 'Mean Manifest Refraction Cylinder at 3 Months', 'timeFrame': 'Month 3', 'description': 'Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.'}, {'measure': 'Mean Uncorrected Visual Acuity (UCVA) at 3 Months', 'timeFrame': 'Month 3', 'description': 'Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;\n* Able to comprehend and sign an informed consent form;\n* Willing and able to complete all postoperative visits;\n* Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.\n* Intended treatment targeted for emmetropia;\n* Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Pregnant or lactating, current or planned, during the course of the study;\n* Dry eye;\n* Corneal disease;\n* Diagnosis of advanced glaucoma;\n* Uncontrolled diabetes;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02987660', 'briefTitle': 'Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax', 'orgStudyIdInfo': {'id': 'RFL605-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LASIK with EX500', 'description': 'Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery', 'interventionNames': ['Procedure: Topography Guided LASIK', 'Device: WaveLight EX500 Excimer Laser System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SMILE with VisuMax', 'description': 'Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery', 'interventionNames': ['Procedure: Small Incision Lenticular Extraction', 'Device: VisuMax Surgical Laser']}], 'interventions': [{'name': 'Topography Guided LASIK', 'type': 'PROCEDURE', 'description': 'Corneal surgery for refractive error correction', 'armGroupLabels': ['LASIK with EX500']}, {'name': 'Small Incision Lenticular Extraction', 'type': 'PROCEDURE', 'otherNames': ['SMILE'], 'description': 'Refractive surgical procedure for the correction of myopia with or without astigmatism', 'armGroupLabels': ['SMILE with VisuMax']}, {'name': 'WaveLight EX500 Excimer Laser System', 'type': 'DEVICE', 'description': "As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.", 'armGroupLabels': ['LASIK with EX500']}, {'name': 'VisuMax Surgical Laser', 'type': 'DEVICE', 'description': "As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.", 'armGroupLabels': ['SMILE with VisuMax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75008', 'city': 'Paris', 'country': 'France', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alcon, A Novartis Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon, a Novartis Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}