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Sponsors and Collaborators: |
University Health Network, Toronto Glaucoma Research Society of Canada |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00775489 |
Patients that have consented to participate in the study will be randomly assigned to one of two groups: control group or nasal steroid group. Assignment will be stratified by surgeon. Patients in the control group will receive normal saline inhaler. Patients in the study group will receive steroid inhaler Patients will be seen on The need for continued follow-up and timely visits will be stressed to the patient during the informed consent process and throughout the study. Time windows for follow-up visits are: recruitment day (45-0 pre-treatment),day 0 (starting treatment day), 1 week , 2 weeks , 4 weeks, 6 week . Intraocular pressures will be recorded on all visits.
Condition | Intervention |
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Intraocular Pressure |
Drug: Nasal steroid Fluticasone Drug: Saline |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Nasal Steroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Nasal steroid Fluticasone
Fluticasone nasal steroids to be given to a very well controlled glaucoma patients to find if this normal dose will lead to increase in iontraocular pressure up to 20% where the study will be stopped at this point.
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2: Placebo Comparator |
Drug: Saline
control group will receive normal saline inhaler
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Systemic and topical ophthalmic steroids have long been associated with ocular effects, such as glaucoma or cataracts.Periocular steroid injections and steroids applied to periocular skin11 have also been reported to increase intraocular pressure (IOP) and raised IOP is the major risk factor for glaucoma. Approximately 18 to 36% of the general population are corticosteroid responders. This response is increased to 46 to 92% in patients with primary open-angle glaucoma (POAG). Allergic rhinitis affects up to 30% of adults and 40% of children in the United States. Topical nasal steroids are the most effective treatment option.Nonallergic rhinitis is a common disease that affects approximately 17 million persons in the United States; approximately 22 million have a combination of allergic and nonallergic rhinitis.Topical nasal steroids have demonstrated efficacy in the treatment of nonallergic rhinitis and are considered first-line empiric therapy.With the perceived safety of nasal steroids, their use for the treatment of upper respiratory allergy has become more common.However, inhaled and nasal steroids might be absorbed systemically. Although the systemic absorption of inhaled and nasal steroids has been established, the clinically relevant ocular side effects are poorly defined. A large prospective study in 1995 by Samiy et alreported no statistically significant increase of IOP in 187 patients without glaucoma taking inhaled steroids for various pulmonary conditions. Similarly, a large case-control study in 1997 cases suggested that the presence of nasal steroid use in patients with newly diagnosed glaucoma or OHT versus nonglaucomatous patients was not statistically significant (odds ratio, 1.02; 95% CI, 0.59-1.77). However, the number of patients taking continuous high-dose nasal steroids was too small for statistical analysis. In 1998, a small prospective study of 26 nonglaucomatous patients revealed no evidence of OHT or cataracts after prolonged use of nasal steroids after endoscopic sinus surgery (mean follow-up, 8.8 ± 3.6 months; range, 3-19 months). A study of 61 patients with seasonal allergic rhinitis taking nasal fluticasone for 1 year showed no increased risk for glaucoma.However, no information was described regarding their glaucoma risk status before steroid use in this study. Six cases of increased IOP associated with combined nasal and inhaled steroid use in nonglaucomatous patients have been reported. Considering the large number of patients on nasal steroids; It is surprising that no one has investigated if nasal steroid use is contraindicated in glaucoma patients.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All of the criteria listed below must be present in the study eye in order for the patient to be eligible for enrollment in the study.
Mild to moderate POAG with cup-disc ratio less than 0.8 vertically and mean deviation of less than −12.00 on Humphrey perimetry.
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Exclusion Criteria:
If any of the following exclusion criteria are present in the study eye, the eye may not be entered into the study.
Contact: University of Toronto; Toronto Western Hospital GE Trope, PhD, FRCSC | (416) 603-5317 | Graham.Trope@uhn.on.ca |
Contact: University of Toronto; Toronto Western Hospital YM Buys, MD, FRCSC | (416) 603-5682 | y.buys@utoronto.ca |
Canada, Ontario | |
University of Toronto; Toronto Western Hospital | |
Toronto, Ontario, Canada |
Responsible Party: | University of Toronto ( Graham Trope / Professor ) |
Study ID Numbers: | UHNToronto001 |
Study First Received: | October 16, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775489 History of Changes |
Health Authority: | United States: Institutional Review Board |
glaucoma,steroid,nasal |
Anti-Inflammatory Agents Glaucoma Eye Diseases Anti-Asthmatic Agents Fluticasone |
Anti-Allergic Agents Peripheral Nervous System Agents Bronchodilator Agents Hypertension Ocular Hypertension |
Anti-Inflammatory Agents Respiratory System Agents Eye Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Glaucoma |
Autonomic Agents Therapeutic Uses Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents Ocular Hypertension |