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Prophylactic Ketorolac Post Epiretinal Membrane Surgery

Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Edema

Intervention: Ketorolac 0.5% (Drug); Saline drops (Other)

Phase: N/A

Status: Completed

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
Jeff Gale, MD, FRCSC, Principal Investigator, Affiliation: Queen's University

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

Department of Ophthalmology, Hotel Dieu Hospital, Queen's University, Kingston, Ontario K7L 3N6, Canada
Additional Information

Starting date: March 2010
Last updated: March 25, 2012

Page last updated: August 23, 2015

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