Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
May 23, 2011 updated by: National Taiwan University Hospital
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 Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Principal Investigator:
- I-Jong Wang, M.D. PhD
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Contact:
- I-Jong Wang, M.D. PhD
- Phone Number: 65729 886-23123456
- Email: ijong@ms8.hinet.net
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
4 men, 3 women, aged 40-90 years old
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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..
|
participants will be monitored after receiving topical ganciclovir,an expected average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: I-Jong Wang, M.D. PhD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
November 1, 2011
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 23, 2011
First Posted (Estimate)
May 25, 2011
Study Record Updates
Last Update Posted (Estimate)
May 25, 2011
Last Update Submitted That Met QC Criteria
May 23, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201010033R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.