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Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01359995
First received: May 16, 2011
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition
Cytomegalovirus Endotheliitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..


Estimated Enrollment: 7
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

4 men, 3 women, aged 40-90 years old

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359995

Contacts
Contact: I-Jong Wang, M.D. PhD 886-23123456 ext 65729 ijong@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: I-Jong Wang, M.D. PhD     886-23123456 ext 65729     ijong@ms8.hinet.net    
Principal Investigator: I-Jong Wang, M.D. PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: I-Jong Wang, M.D. PhD National Taiwan University Hospital
  More Information

Publications:

Responsible Party: I-Jong Wang, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01359995     History of Changes
Other Study ID Numbers: 201010033R
Study First Received: May 16, 2011
Last Updated: May 23, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cytomegalovirus endotheliitis

Additional relevant MeSH terms:
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013