We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Ketorolac Post Epiretinal Membrane Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974753
First Posted: September 10, 2009
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Queen's University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Change in macular volume from baseline. [ Time Frame: Before surgery, at 1 week, 1 month, and 1 year after surgery. ]

Enrollment: 18
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PPV-MP + Placebo (Saline drops)
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:
  • ketorolac tromethamine
  • Apo-Ketorolac
Placebo Comparator: PhacoVit-MP + Placebo (Saline drops)
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:
  • ketorolac tromethamine
  • Apo-Ketorolac

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974753


Locations
Canada, Ontario
Department of Ophthalmology, Hotel Dieu Hospital, Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Jeff Gale, MD, FRCSC Queen's University
  More Information

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT00974753     History of Changes
Other Study ID Numbers: ERM-JG-2009
First Submitted: September 8, 2009
First Posted: September 10, 2009
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Queen's University:
epiretinal membrane

Additional relevant MeSH terms:
Macular Edema
Epiretinal Membrane
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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action