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

Tracking Information

First Received Date ^ICMJE

December 17, 2007

Last Updated Date

December 17, 2007

Start Date ^ICMJE

November 2006

Primary Completion Date

Not Provided

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Surgery

Intervention ^ICMJE

Drug: Ketorolac

Topical use before surgery

Other Name: Acular LS

Study Arm (s)

Placebo Comparator: A
Intervention: Drug: Ketorolac
Experimental: B
Intervention: Drug: Ketorolac

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

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 Number ^ICMJE

NCT00576329

Other Study ID Numbers ^ICMJE

IRB00000517

Has Data Monitoring Committee

Responsible Party

Stephen J. Kim, Emory University

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Not Provided

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

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