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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
  Purpose

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.


Condition Intervention
Glaucoma
Trabeculectomy
Wound Healing
 Procedure: Trabeculectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Cologne:

Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glaucoma patients Procedure: Trabeculectomy
Trabeculectomy with mitomycin C

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the University Eye Hospital of Cologne

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115218

Locations
Germany
University Eye Hospital, University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
  More Information

No publications provided

Responsible Party: Arno Hueber, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT01115218     History of Changes
Other Study ID Numbers: MeVeTra-2009
Study First Received: May 3, 2010
Last Updated: April 12, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013