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Trial record 21 of 25 for:    "Lens Disease" | "Nepafenac"

Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery (PNK)

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: NCT01395069
Recruitment Status : Completed
First Posted : July 15, 2011
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 July 11, 2011
First Posted Date  ICMJE July 15, 2011
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
Change in macular volume (as quantified by OCT) at one month (compared to baseline) [ Time Frame: baseline and one month after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01395069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
COMTOL health-related quality-of-life [ Time Frame: one month after surgery ]
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 Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
Official Title  ICMJE Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)
Brief Summary Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Macular Edema
Intervention  ICMJE
  • Drug: Nepafenac 0.1%
    1 drop QID for 1 month
  • Drug: Ketorolac 0.5%
    1 drop QID for 1 month
  • Other: Placebo (sterile saline drops)
    1 drop QID for 1 month
Study Arms  ICMJE
  • Active Comparator: Nepafenac 0.1%
    Intervention: Drug: Nepafenac 0.1%
  • Active Comparator: Ketorolac 0.5%
    Intervention: Drug: Ketorolac 0.5%
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo (sterile saline drops)
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: July 13, 2011)
162
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to give informed consent
  • Age 18 years and older

Exclusion Criteria:

  • Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
  • Previous uveitis
  • Previous intraocular surgery
  • Allergy or hypersensitivity to NSAIDs
  • Complicated cataract surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01395069
Other Study ID Numbers  ICMJE PNK
Has Data Monitoring Committee No
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 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