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Prophylactic Ketorolac Post Epiretinal Membrane Surgery

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.
 
ClinicalTrials.gov Identifier: NCT00974753
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Queen's University

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
Change in macular volume from baseline. [ Time Frame: Before surgery, at 1 week, 1 month, and 1 year after surgery. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Ketorolac Post Epiretinal Membrane Surgery
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Macular Edema
Intervention  ICMJE
  • 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
  • Other: Saline drops
    Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Study Arms  ICMJE
  • Placebo Comparator: PPV-MP + Placebo (Saline drops)
    PPV-MP= pars plana vitrectomy membrane peel
    Intervention: Other: Saline drops
  • Active Comparator: PPV-MP + Ketorolac 0.5%
    PPV-MP= pars plana vitrectomy membrane peel
    Intervention: Drug: Ketorolac 0.5%
  • Placebo Comparator: PhacoVit-MP + Placebo (Saline drops)
    PhacoVit-MP= phacovitrectomy membrane peel
    Intervention: Other: Saline drops
  • Active Comparator: PhacoVit-MP + Ketorolac 0.5%.
    PhacoVit-MP= phacovitrectomy membrane peel
    Intervention: Drug: Ketorolac 0.5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2012)
18
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
120
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974753
Other Study ID Numbers  ICMJE ERM-JG-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeff Gale, MD, FRCSC Queen's University
PRS Account Queen's University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP