Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-17 @ 10:59 PM
Study NCT ID:
NCT01979250
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057111', 'term': 'Descemet Stripping Endothelial Keratoplasty'}, {'id': 'D016039', 'term': 'Corneal Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Refractive properties, corneal clarity, subjective satisfaction', 'timeFrame': 'Up to 3 years', 'description': 'Subjective satisfaction will be measured using the Catquest 9SF questionnaire which uses a Likert scale which in turn is converted into a Rasch scale. The scales is linear, and uses a unit called the logit.'}], 'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endothelial keratoplasty', "Descemet's stripping automated endothelial keratoplasty", 'lamellar keratoplasty'], 'conditions': ["Fuchs' Endothelial Corneal Dystrophy"]}, 'referencesModule': {'availIpds': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/27273977', 'type': 'Manuscript', 'comment': 'To acces the results, please go to the above mentioned manuscript.'}], 'references': [{'pmid': '27273977', 'type': 'RESULT', 'citation': "Nielsen E, Ivarsen A, Kristensen S, Hjortdal J. Fuchs' endothelial corneal dystrophy: a controlled prospective study on visual recovery after endothelial keratoplasty. Acta Ophthalmol. 2016 Dec;94(8):780-787. doi: 10.1111/aos.13126. Epub 2016 Jun 7."}]}, 'descriptionModule': {'briefSummary': "Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is characterized by changes on the inside of the cornea, which leads to a substantial decline in visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.\n\nCorneal transplantation Corneal transplantation surgery has seen major advances in the last decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has now become the preferred method.\n\nOutcome There have been a substantial number of publications on outcome after DSAEK surgery, and the procedure has several advantages over the former preferred method of transplantation, penetrating keratoplasty (PK).\n\nDespite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far results have been conflicting.\n\nHypotheses\n\n1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs' endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and the type and magnitude of optical disrupting guttae in Descemet's membrane.\n2. The subjective visual function after corneal transplantation with a posterior lamellar graft is correlated with the optical properties of the grafted cornea (thickness, light scatter, irregularities on the anterior, and posterior corneal surfaces)\n\nMaterials and methods\n\nIn a controlled prospective trial of DSAEK patients, we aim to register different morphological patterns, monitor visual performance and optical parameters.\n\nThree sex and age-matched groups will be compared:\n\nGroup 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that undergo cataract surgery.", 'detailedDescription': 'Investigation outline:\n\n* Presence of the following patterns will be registered for each patient: Scattered guttae, confluent guttae, diffuse corneal oedema or confined corneal oedema\n* Refractive properties: Objective and subjective refraction\n* Visual performance: Visual acuity (ETDRS), Contrast sensitivity (FrACT method)\n* Corneal characterization: corneal sensibility (Cochet-Bonnet), In vivo confocal microscopy, specular microscopy, anterior segment OCT, OLCR, Pentacam with densitometry, and slit-lamp investigation will be performed.\n* Catquest 9SF questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fuchs' endothelial dystrophy\n* Candidate for DSAEK surgery\n\nExclusion Criteria:\n\n* other ocular comorbidities that potentially limit vision or contrast vision"}, 'identificationModule': {'nctId': 'NCT01979250', 'briefTitle': "Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology", 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': "Fuchs' Endothelial Dystrophy: Clinical Characteristics, Treatment Outcome, and Pathology", 'orgStudyIdInfo': {'id': 'DSAEKtrial1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normal corneas', 'description': 'Normal corneas from patients that undergo cataract surgery.'}, {'type': 'OTHER', 'label': 'DSAEK surgery', 'description': "Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK).", 'interventionNames': ['Procedure: DSAEK surgery']}], 'interventions': [{'name': 'DSAEK surgery', 'type': 'PROCEDURE', 'otherNames': ['DSEK', 'Endothelial keratoplasty', 'Lamellar keratoplasty', "Descemet's stripping automated endothelial keratoplasty"], 'description': 'Corneal endothelial transplantation by "Descemet\'s stripping automated endothelial keratoplasty" (DSAEK).', 'armGroupLabels': ['DSAEK surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Esben Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Esben Nielsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}