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

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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

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
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)
Study Start Date : February 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. COMTOL health-related quality-of-life [ Time Frame: one month after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: July 15, 2011    Key Record Dates
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