Topical 0.4% Ketorolac and Vitreoretinal Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

December 17, 2007

Last Updated Date

December 17, 2007

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Topical 0.4% Ketorolac and Vitreoretinal Surgery

Official Title ^ICMJE

Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-Controlled, Double-Masked Study

Brief Summary

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

Detailed Description

Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Surgery

Intervention ^ICMJE

Drug: Ketorolac

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00576329

Responsible Party

Stephen J. Kim, Emory University

Study ID Numbers ^ICMJE

IRB00000517

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stephen J Kim, MD

Emory University

Information Provided By

Emory University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP