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

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT01395069
First received: July 11, 2011
Last updated: July 13, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • COMTOL health-related quality-of-life [ Time Frame: one month after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Sherif El-Defrawy, Queen's University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01395069     History of Changes
Other Study ID Numbers: PNK
Study First Received: July 11, 2011
Last Updated: July 13, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Post-cataract surgery
macular edema

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

ClinicalTrials.gov processed this record on April 17, 2014