Topical 0.4% Ketorolac and Vitreoretinal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen Kim, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00576329
First received: December 17, 2007
Last updated: May 12, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Kim, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00576329     History of Changes
Other Study ID Numbers: IRB00000517
Study First Received: December 17, 2007
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014