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Effect of Prophylactic Ketorolac on CME After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335439
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Macular Edema, Cystoid Drug: ketorolac tromethamine 0.5% (Acular®) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography
Study Start Date : June 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • hypersensitivity to the NSAID drug class,
  • pregnancy.

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 identifier (NCT number): NCT00335439

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Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
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Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Hotel Dieu Hospital, Kingston General Hospital, Queen's University
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Responsible Party: Dr. Sherif R El-Defrawy, Principal Investigator, Queen's University Identifier: NCT00335439    
Other Study ID Numbers: QUEENS-SRE-2
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Macular Edema
Capsule Opacification
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