Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-21 @ 2:44 PM
Study NCT ID:
NCT03685851
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Operative Visual Acuity for DSAEK and UT-DSAEK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative visual acuity', 'timeFrame': 'Month 6', 'description': 'postoperative visual acuity in logmar'}], 'secondaryOutcomes': [{'measure': 'Pachymetry', 'timeFrame': 'Month 6', 'description': 'Measurement of the thickness of the cornea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Transplant']}, 'descriptionModule': {'briefSummary': 'To study the correlation between graft size in DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) and UT (ultra thin)-DSAEK type corneal transplants to the visual acuity 6 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent DSAEK surgery between february 2012 and june 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent DSAEK surgery\n* Patients in department of ophthalmology between february 2012 and june 2017\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03685851', 'acronym': 'POVIAD', 'briefTitle': 'Post Operative Visual Acuity for DSAEK and UT-DSAEK', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Post Operative Visual Acuity for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and UT-DSAEK', 'orgStudyIdInfo': {'id': '2017-04Obs-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UT-DSAEK', 'description': 'With graft 6 months thick less than 100 µm', 'interventionNames': ['Procedure: DSAEK type corneal transplant']}, {'label': 'DSAEK', 'description': 'With graft thicker than 100 µm', 'interventionNames': ['Procedure: DSAEK type corneal transplant']}], 'interventions': [{'name': 'DSAEK type corneal transplant', 'type': 'PROCEDURE', 'description': 'All surgeries were performed by the same surgeon and according to the same protocol', 'armGroupLabels': ['DSAEK', 'UT-DSAEK']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}