Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02675751
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skasthur@its.jnj.com', 'phone': '+1 408-273-4081', 'title': 'Sanjeev Kasthurirangan Ph.D.', 'organization': 'Johnson & Johnson Surgical Vision'}, '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': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'PRK Correction With iDesign System and STAR S4 IR Laser', 'description': 'Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 0, 'seriousNumAtRisk': 167, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'seriousEvents': [{'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Abrasions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Infiltrate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Haze', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRK Correction With iDesign System and STAR S4 IR Laser', 'description': 'Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser'}], 'classes': [{'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRK Correction With iDesign System and STAR S4 IR Laser', 'description': 'Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants 167\n\nUnits (eyes) 334', 'achievements': [{'groupId': 'FG000', 'numUnits': '334', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'comment': 'Participants 151\n\nUnits (eyes) 302', 'achievements': [{'groupId': 'FG000', 'numUnits': '302', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': '235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '334', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PRK Correction With iDesign System and STAR S4 IR Laser', 'description': 'Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '5.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-17', 'size': 889508, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-23T13:31', 'hasProtocol': True}, {'date': '2015-11-18', 'size': 743397, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-23T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2016-02-03', 'resultsFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-05', 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better', 'timeFrame': '6 months', 'description': 'At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['myopia'], 'conditions': ['Stable Myopic Refractive Error, With or Without Astigmatism']}, 'referencesModule': {'references': [{'pmid': '36730946', 'type': 'DERIVED', 'citation': 'Hofmeister EM, Cason JB, Murdoch DM, Yau IW, Wang Y, Parizadeh DD, Janakiraman DP, Kasthurirangan S. Wavefront-guided PRK treatment of myopia using a refractive aberrometer. J Cataract Refract Surg. 2023 Mar 1;49(3):292-298. doi: 10.1097/j.jcrs.0000000000001083.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'NOTE: Enrollment open only to military personnel\n\nInclusion Criteria:\n\n* Signed informed consent and HIPAA authorization.\n* Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.\n* Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.\n* Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better\n* BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).\n* Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.\n* Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.\n* Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability\n* Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.\n* Willing and capable of complying with 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, or not using an adequate method of birth control.\n* Concurrent use of systemic (including inhaled) medications that may impair healing.\n* History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.\n* Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.\n* History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.\n* Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography\n* Known sensitivity or inappropriate responsiveness to any of the medications used in this study.\n* If either eye does not meet all inclusion criteria\n* Desire to have monovision.\n* Participation in any other clinical study, with the exception of the fellow eye in this study.'}, 'identificationModule': {'nctId': 'NCT02675751', 'briefTitle': 'Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System', 'orgStudyIdInfo': {'id': 'STAR-115-MIPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wavefront-guided PRK with iDesign', 'description': 'wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser', 'interventionNames': ['Device: STAR S4 IR laser with iDesign']}], 'interventions': [{'name': 'STAR S4 IR laser with iDesign', 'type': 'DEVICE', 'description': 'Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.', 'armGroupLabels': ['wavefront-guided PRK with iDesign']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Surgical Vision Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Surgical Vision, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}