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Topical 0.4% Ketorolac and Vitreoretinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00576329
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Stephen Kim, MD, Emory University

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE December 19, 2007
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE November 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Change in pupil size during vitreoretinal surgery [ Time Frame: Surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Postoperative pain and inflammation [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Surgery
Intervention  ICMJE Drug: Ketorolac
Topical use before surgery
Other Name: Acular LS
Study Arms  ICMJE
  • 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. doi: 10.1001/archopht.126.9.1203.

*   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
Actual Enrollment  ICMJE
 (submitted: December 17, 2007)
76
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00576329
Other Study ID Numbers  ICMJE IRB00000517
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Kim, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen J Kim, MD Emory University
PRS Account Emory University
Verification Date May 2014

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