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

December 17, 2007
December 17, 2007
November 2006
Not Provided
Change in pupil size during vitreoretinal surgery [ Time Frame: Surgery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Postoperative pain and inflammation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Topical 0.4% Ketorolac and Vitreoretinal Surgery
Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-Controlled, Double-Masked Study

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Surgery
Drug: Ketorolac
Topical use before surgery
Other Name: Acular LS
  • Placebo Comparator: A
    Intervention: Drug: Ketorolac
  • Experimental: B
    Intervention: Drug: Ketorolac
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.
 
Completed
76
October 2007
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576329
IRB00000517
No
Stephen J. Kim, Emory University
Emory University
Not Provided
Principal Investigator: Stephen J Kim, MD Emory University
Emory University
December 2007

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