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Topical 0.4% Ketorolac and Vitreoretinal Surgery

This study has been completed.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00576329
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen J. Kim, Emory University
ClinicalTrials.gov 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
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on May 19, 2013