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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00410267 |
Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma. After SLT, many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye (the part in front of the colored part of the eye). This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma. Topical (applied to the surface) corticosteroids can cause an increase in the pressure of the eye (intraocular pressure or IOP), cataract formation, or a possible increase in infection with long-term use. These side effects have not been reported to occur with NSAIDs, which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation, swelling, tenderness, and soreness.
This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation after surgery.
Condition |
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Postoperative Complications Inflammation Glaucoma, Open-Angle |
Study Type: | Observational |
Official Title: | A Randomized Prospective Double - Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-Selective Laser Trabeculoplasty Anterior Chamber Flare and Cells |
Enrollment: | 1 |
Study Start Date: | February 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Selective laser trabeculoplasty (SLT) is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma. After SLT, many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye (the part in front of the colored part of the eye). This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs). Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma. Topical (applied to the surface) corticosteroids can cause an increase in the pressure of the eye (intraocular pressure or IOP), cataract formation, or a possible increase in infection with long-term use. These side effects have not been reported to occur with NSAIDs, which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation, swelling, tenderness, and soreness.
This research study will compare an NSAID, ketorolac tromethamine 0.4% (Acular LS), with a corticosteroid, prednisolone acetate 1% (Pred Forte), and with a placebo, which contains no active medicine (Refresh Tears). Ketorolac tromethamine 0.4%, prednisolone acetate 1%, and Refresh Tears are all FDA (Food and Drug Administration) approved for use in inflammation after surgery.
To date, there is no study that proves that any one of the three study medications is better than the others for care after SLT. We plan to compare the effect of these anti-inflammatory drops in participants after selective laser trabeculoplasty to see if one works better at helping lower the pressure inside the eye after SLT or whether participants would do just as well with non-medicated eye drops. We will also see how well these drops reduce any potential discomfort and swelling that arise.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh (UPMC Eye Center) | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Robert J Noecker, MD | University of Pittsburgh |
Study Chair: | Joel S Schuman, MD | University of Pittsburgh |
Study ID Numbers: | 0511006 |
Study First Received: | December 11, 2006 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00410267 History of Changes |
Health Authority: | United States: Institutional Review Board |
glaucoma Post operative from selective laser trabeculoplasty |
Anti-Inflammatory Agents Methylprednisolone Hormone Antagonists Ketorolac Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Glaucoma Glaucoma, Open-Angle Anti-Inflammatory Agents, Non-Steroidal Analgesics Methylprednisolone Hemisuccinate |
Antineoplastic Agents, Hormonal Eye Diseases Cyclooxygenase Inhibitors Methylprednisolone acetate Glucocorticoids Inflammation Postoperative Complications Analgesics, Non-Narcotic Prednisolone Peripheral Nervous System Agents Antirheumatic Agents Ketorolac Tromethamine Hypertension Ocular Hypertension |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Methylprednisolone Antineoplastic Agents Ketorolac Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Pathologic Processes Sensory System Agents Glaucoma Glaucoma, Open-Angle |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Eye Diseases Cyclooxygenase Inhibitors Gastrointestinal Agents Methylprednisolone acetate Enzyme Inhibitors Protective Agents Glucocorticoids Pharmacologic Actions Inflammation Postoperative Complications |