Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
Study NCT ID:
NCT01359995
Status:
UNKNOWN
Last Update Posted:
2011-05-25
First Post:
2011-05-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-23', 'studyFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical courses before and after topical ganciclovir in patients with CMV endotheliitis', 'timeFrame': 'participants will be monitored after receiving topical ganciclovir,an expected average of 1 year', 'description': 'evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cytomegalovirus endotheliitis'], 'conditions': ['Cytomegalovirus Endotheliitis']}, 'referencesModule': {'references': [{'pmid': '17669498', 'type': 'BACKGROUND', 'citation': 'Koizumi N, Suzuki T, Uno T, Chihara H, Shiraishi A, Hara Y, Inatomi T, Sotozono C, Kawasaki S, Yamasaki K, Mochida C, Ohashi Y, Kinoshita S. Cytomegalovirus as an etiologic factor in corneal endotheliitis. Ophthalmology. 2008 Feb;115(2):292-297.e3. doi: 10.1016/j.ophtha.2007.04.053. Epub 2007 Jul 31.'}, {'pmid': '18255045', 'type': 'BACKGROUND', 'citation': 'Chee SP, Bacsal K, Jap A, Se-Thoe SY, Cheng CL, Tan BH. Clinical features of cytomegalovirus anterior uveitis in immunocompetent patients. Am J Ophthalmol. 2008 May;145(5):834-40. doi: 10.1016/j.ajo.2007.12.015. Epub 2008 Feb 6.'}, {'pmid': '19195708', 'type': 'BACKGROUND', 'citation': "Anshu A, Chee SP, Mehta JS, Tan DT. Cytomegalovirus endotheliitis in Descemet's stripping endothelial keratoplasty. Ophthalmology. 2009 Apr;116(4):624-30. doi: 10.1016/j.ophtha.2008.10.031. Epub 2009 Feb 4."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.', 'detailedDescription': 'In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.\n\nThe purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '4 men, 3 women, aged 40-90 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty\n\nExclusion Criteria:\n\n* patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use'}, 'identificationModule': {'nctId': 'NCT01359995', 'briefTitle': 'Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis', 'orgStudyIdInfo': {'id': '201010033R'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Jong Wang, M.D. PhD', 'role': 'CONTACT', 'email': 'ijong@ms8.hinet.net', 'phone': '886-23123456', 'phoneExt': '65729'}, {'name': 'I-Jong Wang, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'I-Jong Wang, M.D. PhD', 'role': 'CONTACT', 'email': 'ijong@ntu.edu.tw', 'phone': '886-23123456', 'phoneExt': '65729'}], 'overallOfficials': [{'name': 'I-Jong Wang, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'I-Jong Wang', 'oldOrganization': 'Department of Ophthalmology'}}}}