Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 12:31 AM
Study NCT ID:
NCT03685734
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2018-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '1 year', 'description': 'Scored with reference to the logarithm of the minimum angle of resolution (logMAR) and its variation in line gain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DSAEK'], 'conditions': ['Corneal Endothelial Disorder']}, 'descriptionModule': {'briefSummary': 'To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).', 'detailedDescription': 'Since 2006, the technique by removing the Descemet membrane from the recipient cornea was renamed Descemet stripping automated endothelial keratoplasty (DSAEK). In recent years, DSAEK techniques have evolved, favoring increasingly thinner and finer grafts, known as ultrathin DSAEK (UT DSAEK), with the aim of obtaining better visual results.\n\nEndothelial keratoplasty is now the most common surgical procedure used to treat endothelial dysfunction. The current study focused on assessing both objective and subjective visual quality outcomes following DSAEK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with corneal endothelial dysfunction underwent DSAEK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical eligibility for DSAEK\n* Informed written consent\n* Successful completion of DSAEK procedure\n* Postoperative follow-up at least 1 year\n* Ability to respond to the questionnaire\n\nExclusion Criteria:\n\n* Patients with clinical edematous cornea\n* With significant stromal opacity\n* With major disturbances of ocular surface\n* Previous corneal surgery'}, 'identificationModule': {'nctId': 'NCT03685734', 'acronym': 'VO-DSAEK', 'briefTitle': 'Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty for Corneal Endothelial Dysfunction', 'orgStudyIdInfo': {'id': '2015-13Obs-CHRMT'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}