The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy

This study has been completed.

Sponsor:

Information provided by:

University of Cologne

ClinicalTrials.gov Identifier:

NCT01115218

First received: May 3, 2010

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2010
Last Updated Date	April 12, 2013
Start Date ^ICMJE	October 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01115218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Official Title ^ICMJE	The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Brief Summary	The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients from the University Eye Hospital of Cologne
Condition ^ICMJE	Glaucoma Trabeculectomy Wound Healing
Intervention ^ICMJE	Procedure: Trabeculectomy Trabeculectomy with mitomycin C
Study Group/Cohort (s)	Glaucoma patients Intervention: Procedure: Trabeculectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	March 2012
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients with glaucoma with a trabeculectomy required 60 eyes of 60 patients, The ratio of female / male is not involved. Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table). age of at least 18 years Exclusion Criteria: all patients not included in the group of inclusion criteria. less than 50yl anterior chamber fluid could be collected during the operation.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01115218
Other Study ID Numbers ^ICMJE	MeVeTra-2009
Has Data Monitoring Committee	No
Responsible Party	Arno Hueber, MD, University of Cologne
Study Sponsor ^ICMJE	University of Cologne
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Cologne
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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