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Topical 0.4% Ketorolac and Vitreoretinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576329
First Posted: December 19, 2007
Last Update Posted: May 14, 2014
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.
Information provided by (Responsible Party):
Stephen Kim, MD, Emory University
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00576329


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Kim, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00576329     History of Changes
Other Study ID Numbers: IRB00000517
First Submitted: December 17, 2007
First Posted: December 19, 2007
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:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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