Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-11 @ 4:02 AM
Study NCT ID:
NCT02470793
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2015-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technique And Results In Endothelial Keratoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055954', 'term': 'Corneal Endothelial Cell Loss'}, {'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2015-06-06', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'First six months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Endothelial cell density', 'timeFrame': 'First six months postoperatively'}, {'measure': 'Intraoperative complications', 'timeFrame': 'First six months postoperatively'}, {'measure': 'Postoperative complications', 'timeFrame': 'First six months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Corneal Endothelial Cell Loss', "Fuchs' Endothelial Dystrophy", 'Lamellar Keratoplasty', 'Descemet Stripping Endothelial Keratoplasty', 'Descemet Membrane Endothelial Keratoplasty', 'Minimal Surgical Procedure'], 'conditions': ['Corneal Endothelial Cell Loss', "Fuchs' Endothelial Dystrophy"]}, 'descriptionModule': {'briefSummary': 'To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.\n2. Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02470793', 'acronym': 'TREK', 'briefTitle': 'Technique And Results In Endothelial Keratoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Mutua de Terrassa'}, 'officialTitle': 'Technique And Results Evaluation In Endothelial Keratoplasty', 'orgStudyIdInfo': {'id': '00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DSAEK group', 'description': 'Subjects operated of Descemet Stripping Automated Endothelial Keratoplasty.', 'interventionNames': ['Procedure: Descemet Stripping Automated Endothelial Keratoplasty']}, {'type': 'EXPERIMENTAL', 'label': 'DMEK group', 'description': 'Subjects operated of Descemet Membrane Endothelial Keratoplasty.', 'interventionNames': ['Procedure: Descemet Membrane Endothelial Keratoplasty']}], 'interventions': [{'name': 'Descemet Stripping Automated Endothelial Keratoplasty', 'type': 'PROCEDURE', 'otherNames': ['DSAEK', 'DSEK'], 'description': 'Descemet Stripping Automated Endothelial Keratoplasty', 'armGroupLabels': ['DSAEK group']}, {'name': 'Descemet Membrane Endothelial Keratoplasty', 'type': 'PROCEDURE', 'otherNames': ['DMEK'], 'description': 'Descemet Membrane Endothelial Keratoplasty', 'armGroupLabels': ['DMEK group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Mutua Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Eduard Pedemonte-Sarrias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Mútua Terrassa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EDUARD PEDEMONTE-SARRIAS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MEDICAL DOCTOR', 'investigatorFullName': 'EDUARD PEDEMONTE-SARRIAS', 'investigatorAffiliation': 'Hospital Mutua de Terrassa'}}}}