Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-11 @ 5:06 AM
Study NCT ID:
NCT03122535
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2017-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.nuttall@hsc.utah.edu', 'phone': '8012133461', 'title': 'Elizabeth Nuttall', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'No risk for mortality from treatment', 'eventGroups': [{'id': 'EG000', 'title': 'FS-LASIK 70 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.", 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 2, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FS-LASIK 110 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.", 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 2, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Enhancement Needed', 'notes': 'Eye needed an enhancement as uncorrected visual acuity was deemed unacceptable and needed to be improved with additional treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uncorrected Visual Acuity at One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS-LASIK 70 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}, {'id': 'OG001', 'title': 'FS-LASIK 110 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.082', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '-0.094', 'spread': '0.072', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'Vision testing without correction, both eyes using Snellen Eye chart', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a contralateral eye study of 115 subjects, each with one eye randomized to the two study groups.'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity at Year One', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS-LASIK 70 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}, {'id': 'OG001', 'title': 'FS-LASIK 110 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.109', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '-0.116', 'spread': '0.060', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'Vision testing with correction, both eyes using Snellen Eye chart', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FS-LASIK 70 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}, {'id': 'FG001', 'title': 'FS-LASIK 110 Degree Side-cut Angle', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '115', 'numSubjects': '115'}, {'groupId': 'FG001', 'numUnits': '115', 'numSubjects': '115'}]}, {'type': '3 Months', 'achievements': [{'groupId': 'FG000', 'numUnits': '92', 'numSubjects': '92'}, {'groupId': 'FG001', 'numUnits': '92', 'numSubjects': '92'}]}, {'type': '12 Months', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '42'}, {'groupId': 'FG001', 'numUnits': '42', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '42'}, {'groupId': 'FG001', 'numUnits': '42', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '73', 'numSubjects': '73'}, {'groupId': 'FG001', 'numUnits': '73', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': "Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.\n\nFS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.\n\nFS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.96', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-05', 'size': 998286, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-04T12:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Each participant will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2017-02-18', 'resultsFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-04', 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Visual Acuity at One Year', 'timeFrame': 'one year', 'description': 'Vision testing without correction, both eyes using Snellen Eye chart'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity at Year One', 'timeFrame': 'one year', 'description': 'Vision testing with correction, both eyes using Snellen Eye chart'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femtosecond LASIK (FS--LASIK)', 'Visual acuity', 'Refractive errors', 'Side-cut angles'], 'conditions': ['Operative Incision']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).', 'detailedDescription': "LASIK has become the preferred corneal procedure to correct certain refractive errors. One of the major advancements in LASIK has been the introduction of Femtosecond Laser technology for flap creation. Several studies have compared microkeratome and femtosecond laser technology, showing superior accuracy and precision of flap dimensions in the latter.\n\nThe Femtosecond Laser technology provides different parameters and settings that can be changed according to the surgeon's preference. One of such parameters is the side-cut angle. Some of the most common side-cut angles used today include 45, 70, 90, and 110 degrees. Previous studies have reported on the visual outcomes of side-cut angles, but head to head comparisons are lacking. Currently, there are no studies comparing the safety and efficacy of the 70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and complication rates between these side-cut angles will provide an objective measure that can be used when deciding which one is more suitable in FS-LASIK.\n\nOne angle will be performed on the right eye and the other on the left eye. The study will evaluate uncorrected visual acuity, best corrected visual acuity, intraoperative, and postoperative complications. Performing different side-cut angles on the same individual will allow a direct comparison of outcomes, minimizing confounding variables."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.\n\nExclusion Criteria:\n\n* Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.'}, 'identificationModule': {'nctId': 'NCT03122535', 'briefTitle': '70 vs 110 Degree Side-cut Angles in Femtosecond LASIK', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': '70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis', 'orgStudyIdInfo': {'id': 'IRB 74858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FS-LASIK 70 degree side-cut angle', 'description': 'Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.', 'interventionNames': ['Device: FS-LASIK 70 degree side-cut angle', 'Device: FS-LASIK 110 degree side-cut angle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FS-LASIK 110 degree side-cut angle', 'description': 'Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.', 'interventionNames': ['Device: FS-LASIK 70 degree side-cut angle', 'Device: FS-LASIK 110 degree side-cut angle']}], 'interventions': [{'name': 'FS-LASIK 70 degree side-cut angle', 'type': 'DEVICE', 'description': "FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.", 'armGroupLabels': ['FS-LASIK 110 degree side-cut angle', 'FS-LASIK 70 degree side-cut angle']}, {'name': 'FS-LASIK 110 degree side-cut angle', 'type': 'DEVICE', 'description': "FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.", 'armGroupLabels': ['FS-LASIK 110 degree side-cut angle', 'FS-LASIK 70 degree side-cut angle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah John A. Moran Eye Center - Midvalley Location', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'overallOfficials': [{'name': 'Mark D Mifflin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Moran Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Ophthalmology/Visual Sciences', 'investigatorFullName': 'Mark Mifflin', 'investigatorAffiliation': 'University of Utah'}}}}