Effect of Prophylactic Ketorolac on CME After Cataract Surgery - Full Text View

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®)

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Cataract Edema

ChemIDplus related topics:

Ketorolac Ketorolac tromethamine Tromethamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography

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

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

Study placed in the following topic categories:

Signs and Symptoms

Macular Edema

Eye Diseases

Cataract

Ketorolac

Retinal Degeneration

Macular Degeneration

Edema

Ketorolac Tromethamine

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00335439