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Effect of Prophylactic Ketorolac on CME After Cataract Surgery

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00335439
First received: June 8, 2006
Last updated: June 5, 2007
Last verified: May 2006
History of Changes
  Purpose

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:

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00335439     History of Changes
Other Study ID Numbers: QUEENS-SRE-2
Study First Received: June 8, 2006
Last Updated: June 5, 2007
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 18, 2013