Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01537393
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cornea Preservation Time Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jonathan.Lass@UHhospitals.org', 'phone': '2168448368', 'title': 'Dr. Jonathan Lass', 'organization': 'CaseWestern'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 5 years', 'description': 'Adverse event was collected at eye level', 'eventGroups': [{'id': 'EG000', 'title': '0-7d Preservation Time Group', 'description': 'Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.', 'otherNumAtRisk': 675, 'deathsNumAtRisk': 675, 'otherNumAffected': 0, 'seriousNumAtRisk': 675, 'deathsNumAffected': 20, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '8-14d Preservation Time Group', 'description': 'Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.', 'otherNumAtRisk': 654, 'deathsNumAtRisk': 654, 'otherNumAffected': 0, 'seriousNumAtRisk': 654, 'deathsNumAffected': 32, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Endophthalmitis', 'notes': 'One case of bacterial endophthalmitis occurred in the 0-7d PT group 4 days after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 675, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 654, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Microbial keratitis', 'notes': 'Microbial keratitis (bacterial, fungal, parasitic) within 3 months of endothelial keratoplasty (EK) 2 cases of fungal keratitis occurred in the 8-14d PT group 13 and 43 days after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 675, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 654, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservation Time Group 1', 'description': 'Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}, {'id': 'OG001', 'title': 'Preservation Time Group 2', 'description': 'Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciUpperLimit': '5.4', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.', 'otherAnalysisDescription': 'The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.71', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unadjusted Hazard Ratio', 'nonInferiorityComment': 'Confounding and treatment interactions were assessed in Cox proportional hazards regression models'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Study eye will be assessed for this outcome for 3 years following surgery', 'description': 'Graft failure, defined as the occurrence of one of the following within 3 years of surgery:\n\n* Regrafting of the study eye for any reason\n* Cornea which remains cloudy without clearing, according to the following:\n\n 1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR\n 2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Analyzed number of eyes in each group (Overall 1090 unique participants)'}, {'type': 'PRIMARY', 'title': 'Endothelial Cell Density (ECD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preservation Time Group 1', 'description': 'Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}, {'id': 'OG001', 'title': 'Preservation Time Group 2', 'description': 'Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1722', 'spread': '626', 'groupId': 'OG000'}, {'value': '1642', 'spread': '631', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73', 'ciLowerLimit': '8', 'ciUpperLimit': '138', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor', 'nonInferiorityComment': 'The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.'}], 'paramType': 'MEAN', 'timeFrame': '3 years from surgery', 'description': 'Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.', 'unitOfMeasure': 'Cells per square millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0-7d Preservation Time (PT) Group', 'description': 'Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}, {'id': 'FG001', 'title': '8-14d Preservation Time (PT) Group', 'description': 'Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '1046 eyes from 1151 participants randomized', 'achievements': [{'groupId': 'FG000', 'numUnits': '707', 'numSubjects': '707'}, {'groupId': 'FG001', 'numUnits': '699', 'numSubjects': '698'}]}, {'type': 'COMPLETED', 'comment': 'Study eyes with 3-year visit completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '553', 'numSubjects': '553'}, {'groupId': 'FG001', 'numUnits': '508', 'numSubjects': '507'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '154', 'numSubjects': '154'}, {'groupId': 'FG001', 'numUnits': '191', 'numSubjects': '191'}]}], 'dropWithdraws': [{'type': 'Exclude prior to study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'Failure - Regrafted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Failure - Not regrafted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Censored (severe event unrelated to PT)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'preAssignmentDetails': 'Randomization was at eye level. When both eyes of a participant were included, the eye undergoing surgery 1st was assigned randomly to a PT group and the 2nd eye to the other group. 2 eyes had their assigned donor corneas inadvertently switched, and resulted in 1 of these participants receiving both study eyes from 8-14d group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1090', 'groupId': 'BG002'}]}, {'units': 'eyes', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1330', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preservation Time Group 1', 'description': 'Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}, {'id': 'BG001', 'title': 'Preservation Time Group 2', 'description': 'Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.\n\nCornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '64', 'upperLimit': '76'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '64', 'upperLimit': '77'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '64', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'eyes'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '613', 'groupId': 'BG000'}, {'value': '594', 'groupId': 'BG001'}, {'value': '1207', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'American India or Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than 1 race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'History of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Current cigarette smoker', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Received any immunizations or vaccinations in last 3 mo', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Prior glaucoma surgery', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Glaucoma medication currently being used', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Diagnosis', 'classes': [{'categories': [{'title': 'Pseudophakic corneal edema without FECD', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Aphakic corneal edema without FECD', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Fuchs endothelial corneal dystrophy (FECD)', 'measurements': [{'value': '631', 'groupId': 'BG000'}, {'value': '624', 'groupId': 'BG001'}, {'value': '1255', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy))', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '630', 'groupId': 'BG000'}, {'value': '623', 'groupId': 'BG001'}, {'value': '1253', 'groupId': 'BG002'}]}, {'title': 'Keratoconus', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'EBMD (epithelial basement membrane dystrophy)', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': "During the slit lamp exam performed using the investigator's usual routine, the presence of other corneal dystrophies was recorded; EBMD=epithelial basement membrane dystrophy", 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Stromal corneal vessels present (but not visually significant)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Central subepithelial/stromal scarring present (not affect postoperative stromal clarity assessment)', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Peripheral anterior synechiae present (nongonioscopic)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Preoperative lens status', 'classes': [{'categories': [{'title': 'Phakic', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '692', 'groupId': 'BG002'}]}, {'title': 'Aphakic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Pseudophakic posterior chamber intraocular lens', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': "During the slit lamp exam performed using the investigator's usual routine, the state of the crystalline lens was described as phakic (present), aphakic (removed), or pseudophakic (removed with posterior chamber intraocular lens inserted)", 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Postoperative lens status', 'classes': [{'categories': [{'title': 'Phakic', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Pseudophakic posterior chamber intraocular lens', 'measurements': [{'value': '671', 'groupId': 'BG000'}, {'value': '649', 'groupId': 'BG001'}, {'value': '1320', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}, {'title': 'Intraocular pressure (IOP)', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'eyes'}], 'typeUnitsAnalyzed': 'eyes', 'populationDescription': 'Analyses conducted at eye level. 1330 study eyes of 1090 participants underwent descemet stripping automated endothelial keratoplasty. 480 eyes completed bilateral surgery (240 participants), 1 participant had both eyes received cornea in 8-14 days group. 435 and 414 participants underwent unilateral surgery in 0-7 and 8-14 days groups.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-01', 'size': 733306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-12-04T16:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2012-02-15', 'resultsFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-19', 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery', 'timeFrame': 'Study eye will be assessed for this outcome for 3 years following surgery', 'description': 'Graft failure, defined as the occurrence of one of the following within 3 years of surgery:\n\n* Regrafting of the study eye for any reason\n* Cornea which remains cloudy without clearing, according to the following:\n\n 1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR\n 2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.'}, {'measure': 'Endothelial Cell Density (ECD)', 'timeFrame': '3 years from surgery', 'description': 'Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cornea', 'transplant', 'preservation', 'endothelial keratoplasty'], 'conditions': ['Cornea Preservation Time', 'Endothelial Keratoplasty', 'Transplant Success', 'Endothelial Cell Density']}, 'referencesModule': {'references': [{'pmid': '29127431', 'type': 'RESULT', 'citation': 'Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Navarro LC, Pramanik S, Ross KW, Stulting RD, Terry MA, Tu EY, Verdier DD, Kollman C, Gal RL, Beck RW, Lass JH; Cornea Preservation Time Study Group. Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1401-1409. doi: 10.1001/jamaophthalmol.2017.4989.'}, {'pmid': '29127432', 'type': 'RESULT', 'citation': 'Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Mian SI, Navarro LC, Patel SV, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Kollman C, Gal RL, Beck RW; Cornea Preservation Time Study Group. Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1394-1400. doi: 10.1001/jamaophthalmol.2017.4970.'}, {'pmid': '36036663', 'type': 'DERIVED', 'citation': 'Lass JH, Bailey RJ, Szczotka-Flynn LB, Benetz BA, Soper M, Titus MS, Kollman C, Beck RW; Cornea Preservation Time Study Group. Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study. Cornea. 2022 Dec 1;41(12):1539-1544. doi: 10.1097/ICO.0000000000003108. Epub 2022 Sep 9.'}, {'pmid': '25850706', 'type': 'DERIVED', 'citation': 'Lass JH, Szczotka-Flynn LB, Ayala AR, Benetz BA, Gal RL, Aldave AJ, Corrigan MM, Dunn SP, McCall TL, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Verdier DD; Writing Committee for the Cornea Preservation Time Study Group. Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States. Cornea. 2015 Jun;34(6):601-8. doi: 10.1097/ICO.0000000000000417.'}], 'seeAlsoLinks': [{'url': 'http://cpts.jaeb.org/', 'label': 'Public website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.', 'detailedDescription': 'When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Study Participant Eligibility Criteria\n\n* Study Participant Inclusion Criteria\n\n 1. Age range 30-\\<91 years with minimum life expectancy of at least 3 years.\n 2. Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years.\n 3. Fluent in English or Spanish.\n* Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired\n\nStudy Eye Eligibility Criteria\n\n* Study Eye Inclusion Criteria\n\n 1. Endothelial keratoplasty (EK) is scheduled between 10 and 60 days after enrollment\n\n * The 10-day requirement relates to the need to be able to randomly assign the eye to either intervention group.\n * The 60-day requirement relates to the need to have current eligibility and enrollment data at the time of surgery. If surgery is postponed to \\>60 days after the initial enrollment visit, a new Baseline Visit and eligibility assessment will have to be performed.\n 2. Presence of a condition related to endothelial dysfunction which will be treated by EK.\n* Eligible indications for EK include:\n\n * Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:\n\n * Phakic FECD\n * Phakic FECD with cataract\n\n * Triple procedure including EK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed\n * Aphakic FECD\n * Pseudophakic FECD with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL\n * Aphakic or pseudophakic corneal edema with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL without FECD\n* Study Eye Exclusion Criteria\n\n 1. Prior EK\n 2. Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars)\n 3. Presence of a condition that has a very high probability for failure (e.g., failed EK or Penetrating Keratoplasty (PKP), heavily vascularized cornea, uncontrolled uveitis)\n 4. Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy\n 5. Anterior chamber IOL in study eye prior to or anticipated during EK\n 6. Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK\n 7. Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment\n 8. Stromal vascularization that is visually significant (by investigator's judgment)\n 9. Presence of anterior synechiae (iris to cornea)\n 10. Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours\n 11. Hypotony (Intraocular pressure \\<10 mm Hg)\n 12. Uncontrolled (defined as intraocular pressure \\> 25mm Hg) glaucoma with or without prior filtering surgery or shunt or mini-shunt placement.\n\n * A shunt or mini-shunt is any device implanted to lower intraocular pressure through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that is present in the anterior chamber angle or extends into the anterior chamber.\n 13. Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma\n\n * Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL that also have undergone filtering surgery (without shunt or mini-shunt) in which glaucoma is currently considered under control will be eligible\n 14. Fellow eye visual acuity \\< 20/200 that is not correctable with EK\n\nEligibility Criteria for Second Study Eye\n\n1. Study participant has already enrolled one eye\n2. The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)\n3. EK surgery in second eye is not planned within 6 weeks of EK on first study eye"}, 'identificationModule': {'nctId': 'NCT01537393', 'acronym': 'CPTS', 'briefTitle': 'Cornea Preservation Time Study', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Effect of Corneal Preservation Time on Long-Term Graft Success', 'orgStudyIdInfo': {'id': 'CPTS'}, 'secondaryIdInfos': [{'id': '1U10EY020798-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U10EY020798-01A1', 'type': 'NIH'}, {'id': '1U10EY020797-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U10EY020797-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '0-7d Preservation Time Group', 'description': 'Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant.', 'interventionNames': ['Biological: Cornea tissue transplant']}, {'type': 'OTHER', 'label': '8-14d Preservation Time Group', 'description': 'Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant.', 'interventionNames': ['Biological: Cornea tissue transplant']}], 'interventions': [{'name': 'Cornea tissue transplant', 'type': 'BIOLOGICAL', 'description': 'Cornea tissue preserved 0 to 7 days', 'armGroupLabels': ['0-7d Preservation Time Group']}, {'name': 'Cornea tissue transplant', 'type': 'BIOLOGICAL', 'description': 'Cornea tissue preserved 8 to 14 days.', 'armGroupLabels': ['8-14d Preservation Time Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jules Stein Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Eye Care of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Sight', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Woolfson Eye Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30339', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eye Consultants of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Eye and Eye', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Ophthalmology', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Cornea Consultants', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins/Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21117', 'city': 'Owings Mills', 'state': 'Maryland', 'country': 'United States', 'facility': 'Eye Consultants of Maryland', 'geoPoint': {'lat': 39.41955, 'lon': -76.78025}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan/Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Verdier Eye Center', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Cornea Consultants', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Medical Research Institute', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Cornea Consultants of Albany', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center Eye Institute', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44240', 'city': 'Kent', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northeast Ohio Eye Surgeons', 'geoPoint': {'lat': 41.15367, 'lon': -81.35789}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Medical Eye Center', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Devers Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19053', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Ophthalmic Partners of PA', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Central Pennsylvania Eye Institute', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sadeer Hannush, MD', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Corneal Associates, PC, Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cornea Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Focal Point Vision', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Moran Eye Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Eye Associates Northwest', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Medical Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Jonathan Lass, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Western Reserve University'}, {'name': 'Allison Ayala, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaeb Center for Health Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Charles I Thomas Professor, Dept. of Ophthalmology & Visual Sciences,', 'investigatorFullName': 'Jonathan Lass, MD', 'investigatorAffiliation': 'Case Western Reserve University'}}}}