Status:
COMPLETED
Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Funding for Research in Ophthalmology (FRO)
Conditions:
Glaucoma
Trabeculectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Antiglaucoma medication have been shown to induce subclinical conjunctival inflammation in a considerable proportion of glaucoma patients. Today, trabeculectomy still remains the gold standard as surg...
Detailed Description
This prospective double-blind randomized placebo-controlled clinical trial was approved by our institutional review board and adheres to the tenets of the Declaration of Helsinki. Patients who agree f...
Eligibility Criteria
Inclusion
- consecutive patients planned for first-time trabeculectomy willing to comply with the study requirements and having signed informed consent.
- Study subjects have to be diagnosed with glaucoma disease and on maximal medical antiglaucoma medication for at least half a year.
Exclusion
- monophthalmic patients
- secondary (e.g. inflammatory) glaucoma
- intake of steroids
- history of recurrent corneal herpes infection (considered as contra-indication for steroids)
- allergy to steroids, NSAID's, or the preservative benzalkonium chloride
- history of previous filtering surgery or any other intraocular surgery except cataract removal
- patients not fulfilling study requirements
- not taking their study group medication
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00707421
Start Date
July 1 2005
End Date
May 1 2009
Last Update
May 29 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Leuven
Leuven, Belgium, 3000