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NCT Number: NCT00707421

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Fibrosis Intraocular Pressure Ocular Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Trabeculectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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 for the study had to sign an informed consent.

Eligible subjects will be subsequently allocated into one of three topical study medication groups by a computer-based randomisation programme: the placebo group received artificial lacrimal tears (Liquifilm®), the NSAID group a non-steroidal anti-inflammatory drug (Aculare®, ketorolac), and the CS group a corticosteroid (FML®, fluorometholone). All study medication is made by the same pharmaceutical manufacturer (Allergan™), and contained the preservative benzalkonium chloride. Each subject of the 3 study groups will have to take one drop of their study medication four times daily for one month before filtering surgery in addition to their routine antiglaucoma medication. The trabeculectomy technique will be done according to a modified Moorfields procedure by experienced surgeons (IS, TZ)using a standard fornix-based approach.

Patients will be postoperatively examined on days 1 and 2, at weeks 1, 2, and 4, and at months 3, 6, 12, 18 and 24 following trabeculectomy. IOP will be measured by Goldmann applanation tonometry. IOP outcomes will be the observed IOP values and relative (percentage reduction) IOP reduction as compared to baseline at the different postoperative time points. In addition, complete (without additional postoperative medication) and qualified (with and without additional postoperative medication), and number of postoperative additional treatments (needling, laser suture lysis, needling revision) in the study eye will be assessed.

Statistical Analysis

Before the onset of the study, sample size and power calculations are performed. In addition, a randomization programme was set up. A multivariate regression model was used to compare the IOP evolution between the three groups .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketorolac acetate

Drug

Other names: Aculare, Allergan

Fluorometholone

Drug

Other names: FML, Allergan

artificial lacrimal tears

Drug

Other names: Liquifilm, Allergan

Primary outcomes

  1. Incidence of additional IOP-lowering procedures or postoperative medication; Intraocular pressure evolution

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Funding for Research in Ophthalmology (FRO)

Registry information

Official study title

A Randomized Clinical Trial Comparing Preoperative Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Compared to Placebo With Regard to Clinical Outcomes Following Trabeculectomy.

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 30, 2008
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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