Topical 0.4% Ketorolac and Vitreoretinal Surgery - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00576329

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 II Phase III

Drug Information available for: Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-Controlled, Double-Masked Study

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
A: Placebo Comparator	Drug: Ketorolac Topical use before surgery
B: Experimental	Drug: Ketorolac Topical use before surgery

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

Publications indexed to this study:

Kim SJ, Lo WR, Hubbard GB 3rd, Srivastava SK, Denny JP, Martin DF, Yan J, Bergstrom CS, Cribbs BE, Schwent BJ, Aaberg TM Sr. Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial. Arch Ophthalmol. 2008 Sep;126(9):1203-8.

Responsible Party:	Emory University ( Stephen J. Kim )
Study ID Numbers:	IRB00000517
Study First Received:	December 17, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00576329
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

vitreoretinal surgery, ketorolac, Acular, mydriasis

Study placed in the following topic categories:

Miosis
Ketorolac
Mydriasis
Ketorolac Tromethamine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009