Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT04424550
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}], 'ancestors': [{'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': '6 months', 'description': 'The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months'}, {'measure': 'visual acuity', 'timeFrame': '12 months', 'description': 'The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months'}, {'measure': 'visual acuity', 'timeFrame': '24 months', 'description': 'The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months'}], 'secondaryOutcomes': [{'measure': 'central graft thickness measurements', 'timeFrame': '6 months', 'description': 'central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm)'}, {'measure': 'Type of endothelial graft', 'timeFrame': 'days 1', 'description': 'Type of endothelial graft'}, {'measure': "Donor's ages", 'timeFrame': 'days 1', 'description': "Donor's ages"}, {'measure': "recipient's ages", 'timeFrame': 'day 1', 'description': "recipient's ages"}, {'measure': "Graft's endothelial cell density", 'timeFrame': 'day 1', 'description': "Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD)."}, {'measure': 'Rebubbling rate', 'timeFrame': 'day 1', 'description': 'Rebubbling rate'}, {'measure': 'Preoperative visual acuity', 'timeFrame': 'day 1', 'description': 'Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR).'}, {'measure': "graft's indications", 'timeFrame': 'day 1', 'description': 'The indications of the grafts are different between the DMEK groups and the DSAEK and or UT-DSAEK groups: Fuchs endothelial corneal dystrophies (FECD) and moderated pseudophakic bullous keratopathies (PBK)'}, {'measure': 'surgical time', 'timeFrame': 'day 1', 'description': 'surgical time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DMEK, DSAEK, UT-DSAEK, Endothelial cell'], 'conditions': ['Corneal Dystrophy']}, 'referencesModule': {'references': [{'pmid': '38830189', 'type': 'DERIVED', 'citation': 'Perone JM, Goetz C, Zevering Y, Derumigny A. Principal Component Analysis of a Real-World Cohort of Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Cases: Demonstration of a Powerful Data-Mining Technique for Identifying Areas of Research. Cornea. 2025 Feb 1;44(2):209-220. doi: 10.1097/ICO.0000000000003584. Epub 2024 May 29.'}, {'pmid': '34690269', 'type': 'DERIVED', 'citation': 'Perone JM, Goetz C, Zevering Y, Derumigny A, Bloch F, Vermion JC, Lhuillier L. Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study. Cornea. 2022 Nov 1;41(11):1362-1371. doi: 10.1097/ICO.0000000000002872. Epub 2021 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.', 'detailedDescription': "The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.\n\nIn a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study included patients who had undergone posterior lamellar keratoplasty for FECD or moderate PBK indications with a minimum follow-up period of 24 months. The surgical procedures were either DMEK, DSAEK or UT-DSAEK and were performed by the same experienced surgeon (JMP).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar,\n\nExclusion Criteria:\n\n* Patients with pathologies that may seriously affect VA postoperatively'}, 'identificationModule': {'nctId': 'NCT04424550', 'acronym': 'DEMOGRAFT', 'briefTitle': 'Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy', 'orgStudyIdInfo': {'id': '2020-01Obs-CHRMT'}}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'Chr Metz Thionville', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Jean Marc PERONE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}