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

Glaucoma Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707421
• Other study ID #: FRO Pre-op Med Trab
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: May 28, 2009
• Start date: July 2005
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibrosis
• Glaucoma
• Intraocular Pressure
• Trabeculectomy

Intervention

Drug:
• ketorolac acetate

• fluorometholone

• artificial lacrimal tears

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Funding for Research in Ophthalmology (FRO)

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of additional IOP-lowering procedures or postoperative medication; Intraocular pressure evolution