Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 4:25 PM
Study NCT ID:
NCT01586234
Status:
TERMINATED
Last Update Posted:
2018-04-17
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCT-guided DSAEK Graft Shaping and Smoothing
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.', 'timeFrame': '24 months', 'description': 'To determine whether OCT-guided excimer laser graft shaping improves postoperative visual acuity, including reduction of postoperative hyperopic shift and improvement of the predictability of postoperative refraction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Fuchs' endothelial dystrophy", 'DSAEK', "Descemet's stripping automated endothelial keratoplasty"], 'conditions': ["Fuchs' Endothelial Dystrophy"]}, 'descriptionModule': {'briefSummary': "The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).", 'detailedDescription': 'Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.\n\nDSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Inability to maintain stable fixation for OCT imaging\n* Inability to commit to required visits to complete the study\n* Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery"}, 'identificationModule': {'nctId': 'NCT01586234', 'acronym': 'DSAEK', 'briefTitle': 'OCT-guided DSAEK Graft Shaping and Smoothing', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing', 'orgStudyIdInfo': {'id': 'OHSU IRB#00006612 DSAEK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DSAEK with graft shaping and smoothing', 'interventionNames': ['Procedure: DSAEK with graft shaping and smoothing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard DSAEK', 'interventionNames': ['Procedure: Standard DSAEK']}], 'interventions': [{'name': 'DSAEK with graft shaping and smoothing', 'type': 'PROCEDURE', 'description': '1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea\n2. The tissue on the underside of the cornea (endothelium) will be scraped away\n3. The graft from the donor cornea (previously smoothed with a laser) will be inserted through the incision and placed against the endothelium of the host cornea.', 'armGroupLabels': ['DSAEK with graft shaping and smoothing']}, {'name': 'Standard DSAEK', 'type': 'PROCEDURE', 'description': '1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea\n2. The tissue on the underside of the cornea (endothelium) will be scraped away\n3. The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea.', 'armGroupLabels': ['Standard DSAEK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Devers Eye Insitute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Mark Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Devers Eye Institute, Legacy Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mark Terry, MD, Director of Cornea Services', 'investigatorFullName': 'David Huang', 'investigatorAffiliation': 'Legacy Health System'}}}}