Prophylactic Ketorolac Post Epiretinal Membrane Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Gale, Queen's University
ClinicalTrials.gov Identifier:
NCT00974753
First received: September 8, 2009
Last updated: March 25, 2012
Last verified: October 2011
  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

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. ] [ Designated as safety issue: No ]

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
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
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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeffrey Gale, Division of Surgical Retina, 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, 2012
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
epiretinal membrane

Additional relevant MeSH terms:
Edema
Macular Edema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ketorolac Tromethamine
Ketorolac
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014