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

NCT00707421 | Completed Phase 3

• 1 other identifier: FRO Pre-op Med Trab
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glaucoma; Trabeculectomy; Fibrosis; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

1

PLACEBO COMPARATOR

placebo, artificial tears

Drug: artificial lacrimal tears

3

ACTIVE COMPARATOR

corticosteroid , CS

Drug: fluorometholone

2

ACTIVE COMPARATOR

non-steroidal anti-inflammatory drug, NSAID

Drug: ketorolac acetate

Interventions

ketorolac acetate DRUG

Also known as: Aculare, Allergan

2

fluorometholone DRUG

Also known as: FML, Allergan

3

artificial lacrimal tears DRUG

Also known as: Liquifilm, Allergan

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Funding for Research in Ophthalmology (FRO): collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Glaucoma; Fibrosis

Interventions

Ketorolac; Fluorometholone; Idoxuridine

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 30, 2008
• Study Start: July 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 29, 2009

Record last verified: 2009-05

Locations

BE (1)