Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT05531760
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Graft Detachment Following Dmek
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination', 'timeFrame': 'up to 3 months after surgery', 'description': 'clinical examination and anterior segment optical coherence tomography (AS OCT) examination (appearence of the graft)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Fuchs' Endothelial Corneal Dystrophy", 'Descemet Membrane Endothelial Keratoplasty', 'Pseudophakic Bullous Keratopathy', 'Graft Detachment']}, 'descriptionModule': {'briefSummary': "The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with fuchs endothelial corneal dystrophy and patients with pseudophakic bullous keratopathies requiring corneal transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age with DMEK surgery\n\nExclusion Criteria:\n\n* all associated eye surgery other than cataract surgery\n* all existing anterior segment anomalies'}, 'identificationModule': {'nctId': 'NCT05531760', 'acronym': 'PDF DMEKDETACH', 'briefTitle': 'Predictive Factors of Graft Detachment Following Dmek', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Predictive Factors of Graft Detachment Following Dmek: Retrospective Study About 170 Cases', 'orgStudyIdInfo': {'id': '2022-10Obs-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DMEK-operated eyes without graft detachment', 'description': 'Eyes operated with DMEK without graft detachment', 'interventionNames': ['Procedure: Descemet Membrane Endothelial Keratoplasty']}, {'label': 'DMEK-operated with graft detachment', 'description': 'Eyes operated with DMEK with graft detachment', 'interventionNames': ['Procedure: Descemet Membrane Endothelial Keratoplasty']}], 'interventions': [{'name': 'Descemet Membrane Endothelial Keratoplasty', 'type': 'PROCEDURE', 'description': 'DMEK-operated eyes', 'armGroupLabels': ['DMEK-operated eyes without graft detachment', 'DMEK-operated with graft detachment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville/Hopital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Jean-Marc PERONE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}