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Effect of Prophylactic Ketorolac on CME After Cataract 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: NCT00335439
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 9, 2006
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
Degree of cystoid macular edema by means of OCT (total macular volume) measurements
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
Degree of cystoid macular edema by means of OCT measurements
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
Clinical versus non-clinical cystoid macular edema
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Prophylactic Ketorolac on CME After Cataract Surgery
Official Title  ICMJE Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography
Brief Summary The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Macular Edema, Cystoid
Intervention  ICMJE Drug: ketorolac tromethamine 0.5% (Acular®)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: June 5, 2007)
98
Original Enrollment  ICMJE
 (submitted: June 8, 2006)
100
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First cataract surgery (i.e., first eye).

Exclusion Criteria:

  • hypersensitivity to the NSAID drug class,
  • pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335439
Other Study ID Numbers  ICMJE QUEENS-SRE-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sherif R El-Defrawy, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Hotel Dieu Hospital, Kingston General Hospital, Queen's University
PRS Account Queen's University
Verification Date January 2016

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