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Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

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ClinicalTrials.gov Identifier: NCT01359995
Recruitment Status : Unknown
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date May 16, 2011
First Posted Date May 25, 2011
Last Update Posted Date May 25, 2011
Study Start Date November 2010
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2011)
clinical courses before and after topical ganciclovir in patients with CMV endotheliitis [ Time Frame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year ]
evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Official Title Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Brief Summary 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.
Detailed Description

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 4 men, 3 women, aged 40-90 years old
Condition Cytomegalovirus Endotheliitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 23, 2011)
7
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2011
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty

Exclusion Criteria:

  • patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01359995
Other Study ID Numbers 201010033R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party I-Jong Wang, Department of Ophthalmology
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: I-Jong Wang, M.D. PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date May 2011