Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT00915759
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dha.belvoir.fbch.mbx.wresp-research@health.mil', 'phone': '571-231-1600', 'title': 'Principal Investigator', 'organization': 'Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'ProKera', 'description': 'Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 9, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bandage Contact Lens', 'description': 'Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute non-granulomatous anterior uveitis', 'notes': 'Acute, non-granulomatous anterior uveitis is a common, idiopathic inflammatory process that afflicts the iris and ciliary body.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spontaneous extrusion of the graft (or BCL) at first postop week', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed epithelial healing in early postop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent epithelial defect in early postop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'corneal infiltrates (inflammatory) in early postop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Days to Complete Re-epithelialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'Group 1: ProKera in place until complete corneal re-epithelialization (healing)'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively', 'description': 'measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy', 'unitOfMeasure': 'days to complete re-epithelialization', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-epithelialization (healing).'}, {'type': 'PRIMARY', 'title': 'Number of Days to Complete Re-epithelialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'Group 2: ProKera in place until postoperative day 3'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Group 2: bandage contact lens in place until postoperative day 3'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively', 'description': 'measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy', 'unitOfMeasure': 'days to complete re-epithelialization', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.'}, {'type': 'PRIMARY', 'title': 'Number of Days to Complete Re-epithelialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'Group 3: ProKera in place until postoperative day 1'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Group 3: bandage contact lens in place until postoperative day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively', 'description': 'measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy', 'unitOfMeasure': 'days to complete re-epithelialization', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)', 'unitOfMeasure': 'VAS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of Eyes With Complications/Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'eye', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'title': 'Spontaneous extrusion of the graft (or BCL) at first postop week', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Delayed epithelial healing in early postop', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Persistent epithelial defect in early postop', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Corneal infiltrates (inflammatory) in early postop', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'non-granulomatous anterior uveitis at 1 week postop', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'up to one year post-operatively', 'unitOfMeasure': 'eye', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'one year post-operatively', 'description': 'Uncorrected Distance Visual Acuity', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'one year post-operatively', 'description': 'Manifest spherical equivalent within +/- 0.50 diopters of emmetropia', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of Eyes With Clinically Significant Corneal Haze', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'one year postoperatively', 'description': 'clinically significant corneal haze (grade 2 or higher)', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Tear Total Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'units': 'samples', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProKera', 'description': 'ProKera: ProKera placed in non-dominant eye after PRK'}, {'id': 'OG001', 'title': 'Bandage Contact Lens', 'description': 'Bandage contact lens: Bandage contact lens placed in dominant eye, the current standard after PRK'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month post-operatively', 'description': 'total protein levels', 'unitOfMeasure': 'mg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'samples', 'denomUnitsSelected': 'samples', 'populationDescription': 'samples'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ProKera/Bandage Contact Lens', 'description': 'Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after photorefractive keratectomy (PRK)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'number of participants', 'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'number of participants', 'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ProKera and Bandage Contact Lens', 'description': 'Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2009-06-05', 'resultsFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-19', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Days to Complete Re-epithelialization', 'timeFrame': 'participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively', 'description': 'measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)', 'timeFrame': 'Day 1', 'description': 'measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)'}, {'measure': 'Number of Eyes With Complications/Adverse Events', 'timeFrame': 'up to one year post-operatively'}, {'measure': 'Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively', 'timeFrame': 'one year post-operatively', 'description': 'Uncorrected Distance Visual Acuity'}, {'measure': 'Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively', 'timeFrame': 'one year post-operatively', 'description': 'Manifest spherical equivalent within +/- 0.50 diopters of emmetropia'}, {'measure': 'Number of Eyes With Clinically Significant Corneal Haze', 'timeFrame': 'one year postoperatively', 'description': 'clinically significant corneal haze (grade 2 or higher)'}, {'measure': 'Tear Total Protein Levels', 'timeFrame': '1 month post-operatively', 'description': 'total protein levels'}]}, 'conditionsModule': {'keywords': ['ProKera', 'Amniotic membrane', 'Photorefractive Keratectomy', 'PRK', 'time to re-epithelialization'], 'conditions': ['Corneal Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Active duty US Army Soldiers eligible for care at WRAMC.\n* Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.\n* Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.\n* Consent of the subject's command (active duty) to participate in the study.\n* Access to transportation to meet follow-up requirements.\n\nExclusion Criteria:\n\n* Any reason to be excluded for PRK.\n* Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. \\[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not\\].\n* Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.\n* Any physical or mental impairment that would preclude participation in any of the examinations.\n* Anterior basement membrane dystrophy.\n* History of recurrent epithelial erosion.\n* Significant dry eye (symptomatic with Schirmer test \\< 5 mm at 5 minutes).\n* Other corneal epithelial disorder or healing abnormality.\n* Patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., ProKera) between the eyelid and globe."}, 'identificationModule': {'nctId': 'NCT00915759', 'briefTitle': 'Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy', 'orgStudyIdInfo': {'id': '08-6961'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ProKera', 'interventionNames': ['Device: ProKera']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bandage contact lens', 'interventionNames': ['Device: Bandage contact lens']}], 'interventions': [{'name': 'ProKera', 'type': 'DEVICE', 'description': 'ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)', 'armGroupLabels': ['ProKera']}, {'name': 'Bandage contact lens', 'type': 'DEVICE', 'description': 'Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)', 'armGroupLabels': ['Bandage contact lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20307', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Richard D Stutzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WRNMMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'BioTissue Holdings, Inc', 'class': 'INDUSTRY'}, {'name': "St. John's Hospital", 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}