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Effect of Prophylactic Ketorolac on CME After Cataract Surgery

This study has been completed.
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University Identifier:
First received: June 8, 2006
Last updated: January 12, 2016
Last verified: January 2016
The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

Condition Intervention
Macular Edema, Cystoid
Drug: ketorolac tromethamine 0.5% (Acular®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography

Resource links provided by NLM:

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Degree of cystoid macular edema by means of OCT (total macular volume) measurements

Enrollment: 98
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • First cataract surgery (i.e., first eye).

Exclusion Criteria:

  • hypersensitivity to the NSAID drug class,
  • pregnancy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00335439

Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Hotel Dieu Hospital, Kingston General Hospital, Queen's University
  More Information

Responsible Party: Dr. Sherif R El-Defrawy, Principal Investigator, Queen's University Identifier: NCT00335439     History of Changes
Other Study ID Numbers: QUEENS-SRE-2 
Study First Received: June 8, 2006
Last Updated: January 12, 2016
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Macular Edema
Capsule Opacification
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Signs and Symptoms
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 October 26, 2016