Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 12:59 AM
Study NCT ID:
NCT04469933
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2020-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536439', 'term': 'Corneal endothelial dystrophy type 2'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-operative Central Corneal Thickness (CCT),', 'timeFrame': 'day 1', 'description': 'Pre-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)'}, {'measure': 'Post-operative Central Corneal Thickness (CCT),', 'timeFrame': 'Months 12', 'description': 'Post-operative CCT (μm) measured by an anterior segment optical coherence tomography (AS-OCT; RS-3000; Nidek Co. Ltd, Japan)'}, {'measure': "CCT's delta", 'timeFrame': 'day 15', 'description': "CCT's delta (μm) between pre and D15 post-operatively"}], 'secondaryOutcomes': [{'measure': 'anterior mean keratometry', 'timeFrame': 'day 1', 'description': 'anterior mean keratometry (calculated by an auto keratometer Visionix Luneau L67, France)'}, {'measure': 'pre-operative endothelial cell density ECD', 'timeFrame': 'day1', 'description': 'pre-operative ECD (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)'}, {'measure': 'post-operative endothelial cell density (ECD)', 'timeFrame': '6 months', 'description': 'post-operative ECD at 6 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)'}, {'measure': 'post-operative endothelial cell density (ECD)', 'timeFrame': '12 months', 'description': 'post-operative ECD at 12 months (using a non-contact specular microscope CEM-530; Nidek Co. Ltd, Japan)'}, {'measure': 'pre-operative Visual Acuity', 'timeFrame': 'day 1', 'description': 'pre-operative Visual Acuity (using Monoyer chart and converted it to logMar scale)'}, {'measure': "donors' and recipients' ages", 'timeFrame': 'day 1', 'description': "donors' and recipients' ages"}, {'measure': "recipients' sex", 'timeFrame': 'day 1', 'description': "recipients' sex"}, {'measure': 'rate of rebubbling', 'timeFrame': 'months 6', 'description': 'the rate of rebubbling %(postoperative graft detachment)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fuchs endothelial corneal dystrophy', 'central corneal thickness', 'endothelial cell density', 'keratometry'], 'conditions': ['Endothelial Corneal Dystrophy']}, 'descriptionModule': {'briefSummary': "Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).\n\n82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).", 'detailedDescription': "Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD).\n\nA monocentric retrospective observational study was realized at the Regional Hospital Center of Metz-Thionville, Mercy Hospital, Metz, France.\n\n102 eyes of 82 patients with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery). Surgery was considered successful when best spectacle corrected visual acuity (BSCVA) was 0.1 logMar or less (≥0.8) 1 year postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Included patients' were over 18, had advanced FECD associated with visual symptoms and reduced visual acuity", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 18,\n* had advanced FECD associated with visual symptoms and reduced visual acuity .\n\nExclusion Criteria:\n\n* Prior intraocular surgery other than cataract\n* Other indications for DMEK surgeries than FECD,\n* Eyes with corneal (except FECD), retinal or optic nerve diseases\n* Per-operative difficulties (tear's graft or complicated unfolding graft)\n* Primary graft failure (cornea that failed to clear in the presence of an attached graft)\n* Secondary graft failure (corneal decompensation after an initial period of a functional graft)"}, 'identificationModule': {'nctId': 'NCT04469933', 'acronym': 'GOODRMEK', 'briefTitle': "Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': "Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study About 102 Eyes", 'orgStudyIdInfo': {'id': '2020-03ObsCHRMT'}}, 'contactsLocationsModule': {'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'}}}}