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Topical 0.4% Ketorolac and Vitreoretinal 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. Identifier: NCT00576329
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : May 14, 2014
Information provided by (Responsible Party):
Stephen Kim, MD, Emory University

Brief Summary:
To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Condition or disease Intervention/treatment Phase
Surgery Drug: Ketorolac Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
Study Start Date : November 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00576329

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United States, Georgia
Emory Eye Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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Principal Investigator: Stephen J Kim, MD Emory University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stephen Kim, MD, Principal Investigator, Emory University Identifier: NCT00576329    
Other Study ID Numbers: IRB00000517
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Keywords provided by Stephen Kim, MD, Emory University:
vitreoretinal surgery, ketorolac, Acular, mydriasis
Additional relevant MeSH terms:
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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