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OpenTrials
Completed

NCT Number: NCT00335439

Effect of Prophylactic Ketorolac on CME After Cataract Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • hypersensitivity to the NSAID drug class,
  • pregnancy.

Treatment and study plan

ketorolac tromethamine 0.5% (Acular®)

Drug

Primary outcomes

  1. Degree of cystoid macular edema by means of OCT (total macular volume) measurements

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 9, 2006
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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