Topical 0.4% Ketorolac and Vitreoretinal Surgery

This study has been completed.
Information provided by:
Emory University Identifier:
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

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

Condition Intervention Phase
Drug: Ketorolac
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 Emory University:

Primary Outcome Measures:
  • Change in pupil size during vitreoretinal surgery [ Time Frame: Surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain and inflammation [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided by Emory University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen J. Kim, Emory University Identifier: NCT00576329     History of Changes
Other Study ID Numbers: IRB00000517
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents processed this record on April 14, 2014