Prophylactic Ketorolac Post Epiretinal Membrane Surgery

January 12, 2016 updated by: Queen's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in macular volume from baseline.
Time Frame: Before surgery, at 1 week, 1 month, and 1 year after surgery.
Before surgery, at 1 week, 1 month, and 1 year after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Jeff Gale, MD, FRCSC, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERM-JG-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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