Prophylactic Ketorolac Post Epiretinal Membrane Surgery

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.

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Key information

Conditions

Macular Edema Epiretinal Membrane Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Hotel Dieu Hospital, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac 0.5%

Drug

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Other names: ketorolac tromethamine, Apo-Ketorolac

saline drops

Other

Four-times a day starting one week before surgery and continued for 4 weeks post surgery.

Primary outcomes

Change in macular volume from baseline.

Time frame: Before surgery, at 1 week, 1 month, and 1 year after surgery.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 10, 2009
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed