Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-03-17 @ 10:14 PM
Study NCT ID:
NCT01675492
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020731', 'term': 'Keratomileusis, Laser In Situ'}], 'ancestors': [{'id': 'D048988', 'term': 'Corneal Surgery, Laser'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074431', 'term': 'Keratectomy'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lachelle.arredondo@abbott.com', 'phone': '714-247-8628', 'title': 'Director, Clinical Operations', 'organization': 'Abbott Medical Optics'}, 'certainAgreement': {'otherDetails': 'The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Wave-front Guided LASIK', 'description': 'LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wave-front Guided LASIK', 'description': 'LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 Months', 'description': '\\< 5% of eyes will have a loss of \\> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Uncorrected Visual Acuity (UCVA) of 20/40 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wave-front Guided LASIK', 'description': 'LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 Months', 'description': '85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wave-front Guided LASIK', 'description': 'Vision correction for a mixed astigmatism refraction'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number of patients and eyes (units) treated', 'achievements': [{'groupId': 'FG000', 'numUnits': '149', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'comment': '\\# subjects and eyes completed 24M visit. 149 eyes of 84 subjects completed 3M visit - approval basis', 'achievements': [{'groupId': 'FG000', 'numUnits': '75', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '74', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'study completed early - product approval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}], 'typeUnitsAnalyzed': 'eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Wave-front Guided LASIK', 'description': 'LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '10.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'eyes'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2016-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2012-08-28', 'resultsFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-23', 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)', 'timeFrame': '3 Months', 'description': '\\< 5% of eyes will have a loss of \\> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters'}], 'secondaryOutcomes': [{'measure': 'Uncorrected Visual Acuity (UCVA) of 20/40 or Better', 'timeFrame': '3 Months', 'description': '85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Astigmatism', 'refractive', 'error', 'LASIK'], 'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age at the time of pre-operative exam\n* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better\n* Demonstration of refractive stability\n* Anticipated post-operative stromal bed thickness of at lest 250 microns\n* Willing and capable of returning for follow-up examinations for the duration of the study\n\nExclusion Criteria:\n\n* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study\n* Concurrent use of topical or systemic medications that may impair healing\n* History of any medical conditions that could affect wound healing\n* History of prior intraocular or corneal surgery, active ophthalmic disease,or other ocular abnormality\n* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)\n* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course'}, 'identificationModule': {'nctId': 'NCT01675492', 'briefTitle': 'Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System', 'orgStudyIdInfo': {'id': 'STAR-112-IDMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wave-front guided LASIK', 'interventionNames': ['Device: LASIK']}], 'interventions': [{'name': 'LASIK', 'type': 'DEVICE', 'description': 'Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System', 'armGroupLabels': ['wave-front guided LASIK']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kendra Hileman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Optics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}