Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 surgical treatment of medically uncontrolled glaucoma disease. However, this procedure is associated with variable possible complications, of which subconjunctival fibrosis is the most frequent one. The latter results in a non-functional filtering bleb. As a consequence, either additional interventions such as laser suture lysis, needling, bleb revision or additional IOP-lowering medication is necessary. Previous studies demonstrated a benefit of the use of topical steroids postoperatively in reducing inflammation and subsequent subconjunctival fibrosis. In this perspective, we will prospectively explore the usefulness of topical NSAID or corticosteroid therapy preoperatively as compared to placebo in subjects scheduled for first-time trabeculectomy, without interrupting topical antiglaucoma therapy. This will allow us to determine wether the impact of longterm topical antiglaucoma therapy on subclinical conjunctival inflammation which possibly result in postoperative fibrosis and bleb failure can be reversed by anti-inflammatory medication before filtering surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Funding for Research in Ophthalmology (FRO)
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Fluorometholone; Ketorolac

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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