Prophylactic Ketorolac Post Epiretinal Membrane Surgery
Information source: Queen's University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema
Intervention: Ketorolac 0.5% (Drug); Saline drops (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Queen's University Official(s) and/or principal investigator(s):
Jeff Gale, MD, FRCSC, Principal Investigator, Affiliation: Queen's University
Overall contact:
David Almeida, MD, PhD, MBA, Phone: 613-483-4508, Email: drpa27@yahoo.com
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Change in macular volume from baseline.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- idiopathic epiretinal membrane diagnosis requiring membrane peel surgery
Exclusion Criteria:
- proliferative diabetic retinopathy
- sickle cell retinopathy
- radiation retinopathy
- choroidal folds
- hypersensitivity or allergy to NSAIDs
- wet macular degeneration
- branch retinal vein occlusion (BRVO)
- central retinal vein occlusion (CRVO)
- complicated membrane peel surgery
Locations and Contacts
David Almeida, MD, PhD, MBA, Phone: 613-483-4508, Email: drpa27@yahoo.com
Department of Ophthalmology, Hotel Dieu Hospital, Queen's University, Kingston, Ontario K7L 3N6, Canada; Recruiting
David Almeida, MD, PhD, MBA, Phone: 613-483-4508, Email: drpa27@yahoo.com
Jeff Gale, MD, FRCSC, Principal Investigator
Additional Information
Starting date: March 2010
Last updated: March 25, 2011
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