Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 10:29 AM
Study NCT ID:
NCT04240457
Status:
TERMINATED
Last Update Posted:
2024-12-12
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.lubeck@chicagoarboreye.com', 'phone': '708-798-6633', 'title': 'David Lubeck, MD', 'organization': 'ChicagoArbor Eye Care'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Pulsed, Accelerated', 'description': 'Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional', 'description': 'Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Photophobia', 'notes': 'Subject complained of increased photophobia at the 1 week post-procedure visit. Noted resolved at the 1 mo. visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Keratometry in Diopters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed, Accelerated', 'description': '18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}, {'id': 'OG001', 'title': 'Conventional', 'description': '9mW continuous, 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.3', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '.9', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.9', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Average keratometry across the anterior topography of the cornea computed by a validated topographer', 'unitOfMeasure': 'Diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The study was conducted during the COVID-19 pandemic. Some patients were unable or felt uncomfortable presenting to a physician\'s office for follow-up measurements. These individuals are marked as "lost to follow up"'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity With Spectacles or Contact Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed, Accelerated', 'description': 'Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}, {'id': 'OG001', 'title': 'Conventional', 'description': 'Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': '20/25 or better', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '20/30 - 20/50', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/60 - 20/200', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Worse than 20/200', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 month post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '20/25 or better', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/30 - 20/50', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/60 - 20/200', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Worse than 20/200', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3 months post- procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '20/25 or better', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/30 - 20/50', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '20/60 - 20/200', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Worse than 20/200', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 months post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '20/25 or better', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/30 - 20/50', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/60 - 20/200', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Worse than 20/200', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': '20/25 or better', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/30 - 20/50', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '20/60 - 20/200', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Worse than 20/200', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 year', 'description': 'Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale. Snellen chart was used. Values closer to 20/20 indicate better vision.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Patients recruited at a single center based on physician examination for corneal ectasia in one or both eyes. The first patient was screened for enrollment in June 2020, while the last patient was screened in October 2021.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pulsed, Accelerated', 'description': '18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}, {'id': 'FG001', 'title': 'Conventional', 'description': '9mW continuous, 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pulsed, Accelerated', 'description': 'Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination.\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}, {'id': 'BG001', 'title': 'Conventional', 'description': 'Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes\n\nEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.\n\nRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '31.2', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Patients recruited at a single center based on physician examination for corneal ectasia in one or both eyes. The first patient was screened for enrollment in June 2020, while the last patient was screened in October 2021.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-18', 'size': 1997667, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-28T18:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized at outset'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Treatment of patients with disease'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Study was terminated due to enrollment and other challenges attributable to the Covid-19 public health emergency.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2020-01-22', 'resultsFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-28', 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Keratometry in Diopters', 'timeFrame': '1 year', 'description': 'Average keratometry across the anterior topography of the cornea computed by a validated topographer'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity With Spectacles or Contact Lenses', 'timeFrame': '1 year', 'description': 'Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale. Snellen chart was used. Values closer to 20/20 indicate better vision.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Keratoconus', 'Cornea Ectasia']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.', 'detailedDescription': 'Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure and visual function questionnaire assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers\n\nSubjects who have one or both eyes that meet criteria 1 and one or more of the following criteria will be considered candidates for this study:\n\n1. 12 years of age or older\n2. Presence of central or inferior steepening.\n3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration\n4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:\n\n 1. Fleischer ring\n 2. Vogt's striae\n 3. Decentered corneal apex\n 4. Munson's sign\n 5. Rizzutti's sign\n 6. Apical Corneal scarring consistent with Bowman's breaks\n 7. Scissoring of the retinoscopic reflex\n 8. Crab-claw appearance on topography\n5. Steepest keratometry (Kmax) value ≥ 47.20 D\n6. I-S keratometry difference \\> 1.5 D on the Pentacam map\n7. Posterior corneal elevation \\>16 microns\n8. Thinnest corneal point \\<485 microns\n9. Predicted Post LASIK/PRK stromal ablation depth \\<350 microns or expected keratometry \\>47.2 D, or patients undergoing PRK in keratoconus suspect eyes\n10. Contact Lens Wearers Only:\n\n a. Removal of contact lenses for the required period of time prior to the screening refraction:\n11. Signed written informed consent\n12. Willingness and ability to comply with schedule for follow-up visits\n13. Contact Lens Wearers Only:\n\n 1. Removal of contact lenses for the required period of time prior to the screening refraction:\n\nContact Lens Type Minimum Discontinuation Time: Soft 1 Week, Soft Extended Wear 2 Weeks, Soft Toric 3 Weeks, Rigid Gas Permeable 2 Weeks per decade of wear\n\nExclusion Criteria (any of the following are reasons for exclusion):\n\n1. Eyes classified as either normal or atypical normal on the severity grading scheme.\n2. Corneal pachymetry at the screening exam that is \\<300 microns at the thinnest point in the eye(s) to be treated.\n3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:\n\n 1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)\n 2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus, or in the investigator's opinion, will interfere with the cross-linking procedure.\n4. Pregnancy (including plan to become pregnant) or lactation during the course of the study\n5. A known sensitivity to study medications\n6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.\n7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04240457', 'briefTitle': 'Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Arbor Center for Eye Care'}, 'officialTitle': 'Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions', 'orgStudyIdInfo': {'id': '330019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed, accelerated', 'description': '18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.', 'interventionNames': ['Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': '9mW continuous, 10 minutes of illumination.', 'interventionNames': ['Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.']}], 'interventions': [{'name': 'Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.', 'type': 'COMBINATION_PRODUCT', 'description': 'PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.', 'armGroupLabels': ['Conventional', 'Pulsed, accelerated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60467', 'city': 'Orland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arbor Center for Eye Care', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}], 'overallOfficials': [{'name': 'David Lubeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arbor Center for Eye Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbor Center for Eye Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}