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| Sponsors and Collaborators: |
Universitaire Ziekenhuizen Leuven Funding for Research in Ophthalmology (FRO) |
|---|---|
| Information provided by: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT00707421 |
Purpose
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. Additionally, differences in conjunctival cell profile will be linked to surgical outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Trabeculectomy Fibrosis Intraocular Pressure |
Drug: ketorolac acetate Drug: fluorometholone Drug: artificial lacrimal tears |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Clinical Trial Comparing Preoperative Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Compared to Placebo With Regard to Clinicopathological Outcomes Following Trabeculectomy. |
| Study Start Date: | July 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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. One month prior to surgery, as well as during trabeculectomy before the incision of the conjunctiva, a conjunctival biopsy will be prelevated for histological analysis, this in a standardised way. Afterwards, 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 unqualified (with and without additional postoperative medication), and number of postoperative additional treatments (laser suture lysis, needling, needling revision) in the study eye will be assessed.
Histological Analysis
The effect of the study medication on conjunctival cell profile will be investigated by true conjunctival biopsies of human specimens. Conjunctival biopsies will be snap-frozen and stored at - 80° C until all samples are gathered. Five micron thick frozen sections will be cut, and subsequently stained with Giemsa (toluidine blue) and haematoxilin & eosin for light microscopy examination.
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 .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | University Hospitals Leuven ( Ingeborg Stalmans, MD, PhD ) |
| Study ID Numbers: | FRO Pre-op Med Trab |
| Study First Received: | June 24, 2008 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00707421 |
| Health Authority: | Belgium: Institutional Review Board |
|
Fluorometholone Fibrosis Glaucoma Eye Diseases |
Ketorolac Ketorolac Tromethamine Hypertension Ocular Hypertension |
|
Anti-Inflammatory Agents Pathologic Processes Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Allergic Agents Hormones Glucocorticoids Pharmacologic Actions |
