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

This study has been completed.
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University Identifier:
First received: July 11, 2011
Last updated: January 12, 2016
Last verified: January 2016
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


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

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
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Please refer to this study by its identifier: NCT01395069

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

Responsible Party: Dr. Sherif R El-Defrawy, Principal Investigator, Queen's University Identifier: NCT01395069     History of Changes
Other Study ID Numbers: PNK
Study First Received: July 11, 2011
Last Updated: January 12, 2016

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

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on August 22, 2017