Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04805593
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the WaveLight® EX500 Excimer Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'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': 'alcon.medinfo@alcon.com', 'phone': '18884513937', 'title': 'Clinical Projects Director, Surgical', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year.', 'description': 'AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreament', 'description': 'AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser system.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'WaveLight EX500 Excimer Laser System - Ocular', 'description': 'AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include ocular events in the study eye.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 10, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'WaveLight EX500 Excimer Laser System - Systemic', 'description': 'AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include overall systemic events.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WaveLight EX500 Excimer Laser System', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Exact Test of Binomial Proportion', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)', 'description': 'A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WaveLight EX500 Excimer Laser System', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Exact Test of Binomial Proportion', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)', 'description': 'A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Eyes Experiencing Ocular Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WaveLight EX500 Excimer Laser System', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system'}], 'classes': [{'title': 'Diplopia', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Photophobia', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Visual acuity reduced', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Ocular hyperaemia', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12 postoperative', 'description': 'An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Safety Analysis Set: all eyes for which refractive surgery was attempted with the test device (regardless of success or failure).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WaveLight EX500 Excimer Laser System', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '60', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '60', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Participants were recruited from 5 investigative sites located in 1 country (US).', 'preAssignmentDetails': 'Of the 44 enrolled, 14 participants were discontinued as screen failures prior to attempted surgery. This reporting group includes all enrolled participants/eyes with attempted surgery (30/60, respectively).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'WaveLight EX500 Excimer Laser System', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '10.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: All eyes for which a refractive surgery was attempted with test device (regardless of success or failure).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-26', 'size': 668677, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-26T10:50', 'hasProtocol': True}, {'date': '2023-05-24', 'size': 312831, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-26T10:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2021-03-16', 'resultsFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-26', 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability', 'timeFrame': 'Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)', 'description': 'A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.'}, {'measure': 'Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability', 'timeFrame': 'Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)', 'description': 'A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.'}, {'measure': 'Percentage of Eyes Experiencing Ocular Adverse Events (AEs)', 'timeFrame': 'Up to Month 12 postoperative', 'description': 'An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['LASIK', 'Refractive errors'], 'conditions': ['Hyperopia', 'Hyperopic Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.', 'detailedDescription': 'Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Intended to treat bilaterally;\n* Hyperopia with or without astigmatism as specified in the protocol;\n* Stable vision as specified in the protocol;\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Glaucoma;\n* Cataracts;\n* Previous eye surgery;\n* Intent to have monovision treatment;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04805593', 'briefTitle': 'Clinical Investigation of the WaveLight® EX500 Excimer Laser', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK', 'orgStudyIdInfo': {'id': 'RFD530-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WaveLight EX500 excimer laser system', 'description': 'Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system', 'interventionNames': ['Device: WaveLight EX500 excimer laser system', 'Procedure: LASIK']}], 'interventions': [{'name': 'WaveLight EX500 excimer laser system', 'type': 'DEVICE', 'description': 'FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.', 'armGroupLabels': ['WaveLight EX500 excimer laser system']}, {'name': 'LASIK', 'type': 'PROCEDURE', 'description': 'Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.', 'armGroupLabels': ['WaveLight EX500 excimer laser system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Durrie Vision', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Physicians Protocol', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '58078', 'city': 'West Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision ND', 'geoPoint': {'lat': 46.87497, 'lon': -96.90036}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Mann Eye Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sr. Clinical Trial Lead, Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}