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| Sponsor: | Queen's University |
|---|---|
| Information provided by: | Queen's University |
| ClinicalTrials.gov Identifier: | NCT00974753 |
Purpose
Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.
| Condition | Intervention |
|---|---|
|
Macular Edema |
Drug: Ketorolac 0.5% Other: Saline drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: PPV-MP + Placebo
PPV-MP= pars plana vitrectomy membrane peel
|
Other: Saline drops
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
|
|
Active Comparator: PPV-MP + Ketorolac 0.5%
PPV-MP= pars plana vitrectomy membrane peel
|
Drug: Ketorolac 0.5%
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Other Names:
|
|
Placebo Comparator: PhacoVit-MP + Placebo
PhacoVit-MP= phacovitrectomy membrane peel
|
Other: Saline drops
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
|
|
Active Comparator: PhacoVit-MP + Ketorolac 0.5%.
PhacoVit-MP= phacovitrectomy membrane peel
|
Drug: Ketorolac 0.5%
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Other Names:
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Almeida, MD, PhD, MBA | 613-483-4508 | drpa27@yahoo.com |
| Canada, Ontario | |
| Department of Ophthalmology, Hotel Dieu Hospital, Queen's University | Recruiting |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Contact: David Almeida, MD, PhD, MBA 613-483-4508 drpa27@yahoo.com | |
| Principal Investigator: Jeff Gale, MD, FRCSC | |
| Principal Investigator: | Jeff Gale, MD, FRCSC | Queen's University |
More Information
| Responsible Party: | Dr. Jeff Gale, Department of Ophthalmology, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00974753 History of Changes |
| Other Study ID Numbers: | ERM-JG-2009 |
| Study First Received: | September 8, 2009 |
| Last Updated: | March 25, 2011 |
| Health Authority: | Canada: Health Canada |
|
epiretinal membrane |
|
Edema Macular Edema Epiretinal Membrane Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
