Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-29 @ 3:49 AM
Study NCT ID:
NCT02206594
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2014-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Cataract Surgery and Planned Descemetorhexis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}, {'id': 'D002386', 'term': 'Cataract'}], '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'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2014-04-18', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reconstitution of the endothelial cell layer as assessed by specular microscopy', 'timeFrame': 'Assessed up to 1 year following descemetorhexis'}], 'primaryOutcomes': [{'measure': 'Corneal clarity as assessed by slit lamp photography', 'timeFrame': 'Assessed up to 1 year following descemetorhexis'}], 'secondaryOutcomes': [{'measure': 'Resolution of edema as assessed by slit lamp photography', 'timeFrame': 'Assessed up to 1 year following descemetorhexis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Fuchs' Corneal Dystrophy", 'Cataract']}, 'descriptionModule': {'briefSummary': "A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria:\n\n* Patient \\>18 years old\n* Willing and able to provide informed consent\n\nOcular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):\n\n* Fuchs' corneal dystrophy diagnosed\n* Cataract present\n* Best corrected visual acuity ≤ 20/40\n* Candidate for current endothelial transplant procedure (DSAEK, DMEK)\n\nGeneral Exclusion Criteria:\n\n* \\<18 years old\n* Medically unstable patient\n* Monocular patient\n* Unwilling or unable to provide informed consent\n\nOcular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):\n\n* Corneal dystrophy other than Fuchs'\n* Central corneal scar or central opacity not related to Fuchs'\n* Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy\n* History of prior vitreoretinal surgery\n* Advanced or unstable glaucoma\n* Known steroid responders with glaucoma"}, 'identificationModule': {'nctId': 'NCT02206594', 'briefTitle': 'Combined Cataract Surgery and Planned Descemetorhexis', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Combined Cataract Surgery and Planned Descemetorhexis', 'orgStudyIdInfo': {'id': 'MCW-EI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Descemetorhexis', 'interventionNames': ['Procedure: Descemetorhexis']}], 'interventions': [{'name': 'Descemetorhexis', 'type': 'PROCEDURE', 'armGroupLabels': ['Descemetorhexis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Steven B. Koenig, MD', 'investigatorFullName': 'Steve Koenig', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}