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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395069
First Posted: July 15, 2011
Last Update Posted: January 13, 2016
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.
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University
  Purpose
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).

Condition Intervention Phase
Macular Edema Drug: Nepafenac 0.1% Drug: Ketorolac 0.5% Other: Placebo (sterile saline drops) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Dr. Sherif R El-Defrawy, Queen's University:

Primary Outcome Measures:
  • Change in macular volume (as quantified by OCT) at one month (compared to baseline) [ Time Frame: baseline and one month after surgery ]

Secondary Outcome Measures:
  • COMTOL health-related quality-of-life [ Time Frame: one month after surgery ]

Enrollment: 162
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nepafenac 0.1% Drug: Nepafenac 0.1%
1 drop QID for 1 month
Active Comparator: Ketorolac 0.5% Drug: Ketorolac 0.5%
1 drop QID for 1 month
Placebo Comparator: Placebo Other: Placebo (sterile saline drops)
1 drop QID for 1 month

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395069


Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 3G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Sherif El-Defrawy, MD PhD Queen's University
  More Information

Responsible Party: Dr. Sherif R El-Defrawy, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01395069     History of Changes
Other Study ID Numbers: PNK
First Submitted: July 11, 2011
First Posted: July 15, 2011
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Dr. Sherif R El-Defrawy, Queen's University:
Post-cataract surgery
macular edema

Additional relevant MeSH terms:
Edema
Cataract
Macular Edema
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ketorolac
Ketorolac Tromethamine
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action