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Topical 0.4% Ketorolac and Vitreoretinal Surgery

This study has been completed.
Information provided by (Responsible Party):
Stephen Kim, MD, Emory University Identifier:
First received: December 17, 2007
Last updated: May 12, 2014
Last verified: May 2014
To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Condition Intervention Phase
Surgery Drug: Ketorolac Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-controlled, Double-masked Study

Resource links provided by NLM:

Further study details as provided by Stephen Kim, MD, Emory University:

Primary Outcome Measures:
  • Change in pupil size during vitreoretinal surgery [ Time Frame: Surgery ]

Secondary Outcome Measures:
  • Postoperative pain and inflammation [ Time Frame: 1 day ]

Enrollment: 76
Study Start Date: November 2006
Study Completion Date: October 2007
Arms Assigned Interventions
Placebo Comparator: A Drug: Ketorolac
Topical use before surgery
Other Name: Acular LS
Experimental: B Drug: Ketorolac
Topical use before surgery
Other Name: Acular LS

Detailed Description:
Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age of 18, routine elective vitrectomy

Exclusion Criteria:

  • history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye
  Contacts and Locations
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Please refer to this study by its identifier: NCT00576329

United States, Georgia
Emory Eye Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Stephen J Kim, MD Emory University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen Kim, MD, Principal Investigator, Emory University Identifier: NCT00576329     History of Changes
Other Study ID Numbers: IRB00000517
Study First Received: December 17, 2007
Last Updated: May 12, 2014

Keywords provided by Stephen Kim, MD, Emory University:
vitreoretinal surgery, ketorolac, Acular, mydriasis

Additional relevant MeSH terms:
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on August 22, 2017