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Sponsors and Collaborators: |
Hotel Dieu Hospital Sunnybrook Health Sciences Centre |
Information provided by: | Hotel Dieu Hospital |
ClinicalTrials.gov Identifier: | NCT00744666 |
Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.
Condition | Intervention | Phase |
Vitreoretinal Disease Ocular Hypertension |
Drug: Prednisolone 1% topical eye drops |
Phase IV |
Genetics Home Reference related topics: | early-onset glaucoma |
MedlinePlus related topics: | High Blood Pressure |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-Pressure by Tracking Elevations After Topical Steroids |
Estimated Enrollment: | 70 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is > or equal to 21 mmHg, then IVTA will be withheld. If the IOP < 21mmHg, then patients will receive an injection of IVTA.
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Drug: Prednisolone 1% topical eye drops
Prednisolone 1% 1gtt qid to the eye requiring IVTA
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2: No Intervention
Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenneth Eng, MD, FRCSC | 416-480-4468 | kt_eng@hotmail.com |
Contact: Jeffery Gale, MD, FRCSC | 613-544-3400 ext 3391 | jeffgaleuwo@yahoo.com |
Canada, Ontario | |||||
Sunnybrook Health Sciences Centre | |||||
Toronto, Ontario, Canada, M4N3M5 | |||||
Hotel Dieu Hospital | |||||
Kingston, Ontario, Canada, K7L 5G2 | |||||
Toronto Western Hospital | |||||
Toronto, Ontario, Canada, M5T 2S8 |
Hotel Dieu Hospital |
Sunnybrook Health Sciences Centre |
Principal Investigator: | Kenneth Eng, MD, FRCSC | Sunnybrook Health Sciences Centre |
Principal Investigator: | Jeffery Gale, MD, FRCSC | Hotel Dieu Hospital |
Responsible Party: | Sunnybrook Health Sciences Centre ( Dr. Kenneth Eng ) |
Study ID Numbers: | 07142008 |
First Received: | August 29, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00744666 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
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