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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cataract
Macular Edema
Edema
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Nepafenac
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 September 18, 2014